Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC4014
In Commercial Distribution

  • 10381780116851 ()
  • M268AC40141 ()

  • .551 in L x .157 in dia; .24 in thread
AC4014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC4012
In Commercial Distribution

  • 10381780116844 ()
  • M268AC40121 ()

  • .472 in L x .157 in dia; .24 in thread
AC4012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3040
In Commercial Distribution

  • 10381780116837 ()
  • M268AC30401 ()

  • 1.575 in L x .118 in dia; .53 in thread
AC3040

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3036
In Commercial Distribution

  • 10381780116820 ()
  • M268AC30361 ()

  • 1.417 in L x .118 in dia; .47 in thread
AC3036

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3034
In Commercial Distribution

  • 10381780116813 ()
  • M268AC30341 ()

  • 1.339 in L x .118 in dia; .45 in thread
AC3034

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3032
In Commercial Distribution

  • 10381780116806 ()
  • M268AC30321 ()

  • 1.260 in L x .118 in dia; .42 in thread
AC3032

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3030
In Commercial Distribution

  • 10381780116790 ()
  • M268AC30301 ()

  • 1.181 in L x .118 in dia; .39 in thread
AC3030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3028
In Commercial Distribution

  • 10381780116783 ()
  • M268AC30281 ()

  • 1.102 in L x .118 in dia; .37 in thread
AC3028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3026
In Commercial Distribution

  • 10381780116776 ()
  • M268AC30261 ()

  • 1.024 in L x .118 in dia; .34 in thread
AC3026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3022
In Commercial Distribution

  • 10381780116752 ()
  • M268AC30221 ()

  • .866 in L x .118 in dia; .29 in thread
AC3022

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3020
In Commercial Distribution

  • 10381780116745 ()
  • M268AC30201 ()

  • .787 in L x .118 in dia; .26 in thread
AC3020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3018
In Commercial Distribution

  • 10381780116738 ()
  • M268AC30181 ()

  • .709 in L x .118 in dia; .24 in thread
AC3018

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3016
In Commercial Distribution

  • 10381780116721 ()
  • M268AC30161 ()

  • .630 in L x .118 in dia; .21 in thread
AC3016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3014
In Commercial Distribution

  • 10381780116714 ()
  • M268AC30141 ()

  • .551 in L x .118 in dia; .20 in thread
AC3014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3012
In Commercial Distribution

  • 10381780116707 ()
  • M268AC30121 ()

  • .472 in L x .118 in dia; .20 in thread
AC3012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC3010
In Commercial Distribution

  • 10381780116691 ()
  • M268AC30101 ()

  • .394 in L x .118 in dia; .20 in thread
AC3010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2530
In Commercial Distribution

  • 10381780116684 ()
  • M268AC25301 ()

  • 1.181 in L x .098 in dia; .39 in thread
AC2530

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2528
In Commercial Distribution

  • 10381780116677 ()
  • M268AC25281 ()

  • 1.102 in L x .098 in dia; .37 in thread
AC2528

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2526
In Commercial Distribution

  • 10381780116660 ()
  • M268AC25261 ()

  • 1.024 in L x .098 in dia; .34 in thread
AC2526

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2524
In Commercial Distribution

  • 10381780116653 ()
  • M268AC25241 ()

  • .945 in L x .098 in dia; .32 in thread
AC2524

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2522
In Commercial Distribution

  • 10381780116646 ()
  • M268AC25221 ()

  • .866 in L x .098 in dia; .29 in thread
AC2522

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2520
In Commercial Distribution

  • 10381780116639 ()
  • M268AC25201 ()

  • .787 in L x .098 in dia; .26 in thread
AC2520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Digital screw is a cannulated, threaded bone screw made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AC2516
In Commercial Distribution

  • 10381780116615 ()
  • M268AC25161 ()

  • .630 in L x .098 in dia; .21 in thread
AC2516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression
IMPLANTECH ASSOCIATES, INC.
25cm x122cm (10 in x48 in)
In Commercial Distribution

  • M724WRAP1048NL1 ()
WRAP-1048-NL

  • Scar-management dressing, reusable
Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression
IMPLANTECH ASSOCIATES, INC.
25cmx122cm (10 in x 48 in)
In Commercial Distribution

  • M724WRAP10481 ()
WRAP-1048

  • Scar-management dressing, reusable
U-Drape 4 IN x 44 IN SPLIT 80 in x 124 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09149G-S
In Commercial Distribution

  • 40612479230376 ()
  • 10612479230368 ()


  • Patient surgical drape, single-use
U-Drape 4 IN x 40 IN SPLIT 76 in x 120 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09107G-S
In Commercial Distribution

  • 40612479230352 ()
  • 10612479230344 ()


  • Patient surgical drape, single-use
U-Drape 2.5 IN x 37 IN SPILT 76 in x 110 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09178-S
In Commercial Distribution

  • 40612479230338 ()
  • 10612479230320 ()


  • Patient surgical drape, single-use
U-Drape 2.5 IN x 30 IN SPILT 53 in x 76 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09135G-S
In Commercial Distribution

  • 40612479230314 ()
  • 10612479230306 ()


  • Patient surgical drape, single-use
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The glenoid tray includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Round and oval glenoid trials are also included for evaluation. . Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.
Ascension Orthopedics, Inc.
TSSMINIGLIMP
Not in Commercial Distribution

  • M268TSSMINIGLIMP1 ()
  • 10381780237501 ()

  • 22.3 in L x 9.5 in W x 5.7 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The humeral tray 3 includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.
Ascension Orthopedics, Inc.
TSS3IMP
Not in Commercial Distribution

  • M268TSS3IMP1 ()
  • 10381780237495 ()

  • 22.6 in L x 10.5 in W x 4.2 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. This humeral tray 2 includes centric and eccentric humeral head trials to evaluate the size and fit of the appropriate implants. Head sizing plates are included to find the base width, as well as determine the need for concentric or eccentric, prior to trialing the humeral head. Instruments to assist with the trials and sizing are also included in the set.
Ascension Orthopedics, Inc.
TSS2IMP
Not in Commercial Distribution

  • M268TSS2IMP1 ()
  • 10381780237488 ()

  • 23.2 in L x 10.3 in W x 5.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes five silicone MCP trials to evaluate the size and fit of the implants.
Ascension Orthopedics, Inc.
SILMCPINSTP
Not in Commercial Distribution

  • M268SILMCPINSTP1 ()
  • 10381780237464 ()

  • 9.6 in L x 4.4 in W x 1.5 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization. The set includes proximal trials, distal trials, and silicone trials to evaluate the size and fit of the appropriate implant. Instruments are included to assist with the trials.
Ascension Orthopedics, Inc.
PYROMCPINSTP
Not in Commercial Distribution

  • M268PYROMCPINSTP1 ()
  • 10381780235057 ()

  • 21.7 in L x 10.0 in W x 2.4 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Ascension® PyroHemiSphereTM is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PYROHEMIINSP
Not in Commercial Distribution

  • M268PYROHEMIINSP1 ()
  • 10381780235033 ()

  • 12.9 in L x 8.4 in W x 2.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Ascension Orthopedics, Inc.
MRADHDINSTP
Not in Commercial Distribution

  • M268MRADHDINSTP1 ()
  • 10381780235002 ()

  • 21.9 in L x 10.1 in W x 2.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Ascension Orthopedics, Inc.
FRSTDRUJINSP
Not in Commercial Distribution

  • M268FRSTDRUJINSP1 ()
  • 10381780234951 ()

  • 23.0 in L x 11.5 in W x 4.25 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes silicone PIP trials to evaluate size and fit of the implants. Instruments are also included.
Ascension Orthopedics, Inc.
SILPIPINSTP
Not in Commercial Distribution

  • M268SILPIPINSTP1 ()
  • 10381780235125 ()

  • 21.9 in L x 10.2 in W x 3.0 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra PyroCarbon PIP is indicated for use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction, and when the patient needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage. This set includes proximal and distal trials to evaluate proper size and fit of the implants. Instruments are included for assistance.
Ascension Orthopedics, Inc.
PYROPIPINSTP
Not in Commercial Distribution

  • M268PYROPIPINSTP1 ()
  • 10381780235064 ()

  • 21.8 in L x 9.3 in W x 2.5 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra Lunate system is intended for replacement of the lunate bone in the proximal carpal row of the wrist. The set includes five trials to evaluate the size and fit of the implant. Five sizing templates are also included to assess coverage and establish proper sizing for the component.
Ascension Orthopedics, Inc.
PYROLUNINSTP
Not in Commercial Distribution

  • M268PYROLUNINSTP1 ()
  • 10381780235040 ()

  • 9.0 in L x 6.0 in W x 1.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This set includes trials to evaluate the size and fit of the implant. Instruments are included for assistance.
Ascension Orthopedics, Inc.
NUGRIPINSTP
Not in Commercial Distribution

  • M268NUGRIPINSTP1 ()
  • 10381780235019 ()

  • 21.4 in L x 9.0 in W x 2.9 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Titan Humeral Resurfacing Arthroplasty system is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and/or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff. The set includes HRA trials to evaluate the size and fit of the appropriate implant, as well as sizers to determine the amount of bone resection needed for the implant. Instruments are also included to assist with the trials.
Ascension Orthopedics, Inc.
HRARTHIMP
Not in Commercial Distribution

  • M268HRARTHIMP1 ()
  • 10381780234975 ()

  • 22.4 in L x 10.8 in W x 6.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
Integra® External Fixation System The ExFix Case 5 Bottom is the portion of the case wherein system devices are placed.
Ascension Orthopedics, Inc.
12227005
In Commercial Distribution

  • M269122270051 ()
  • 10381780248217 ()

  • 21.54 in L x 10.84 in W x 4.87 in H
12227005

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Tray 4 Top locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
12227009
In Commercial Distribution

  • M269122270091 ()
  • 10381780248200 ()

  • 21.15 in L x 10.62 in W x 1.69 in H
12227009

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Case 4 Bottom is the portion of the case wherein system devices are placed.
Ascension Orthopedics, Inc.
12227004
In Commercial Distribution

  • M269122270041 ()
  • 10381780248194 ()

  • 21.54 in L x 10.84 in W x 5.30 in H
12227004

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Case 3 Bottom is the portion of the case wherein system devices are placed.
Ascension Orthopedics, Inc.
12227003
In Commercial Distribution

  • M269122270031 ()
  • 10381780248156 ()

  • 21.54 in L x 10.84 in W x 4.38 in H
12227003

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Case 2 is composed of a base and lid designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
12227002
In Commercial Distribution

  • M269122270021 ()
  • 10381780248033 ()

  • 22.27 in L x 10.84 in W x 2.97 in H
12227002

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Washer Caddy 1 is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
12227016
In Commercial Distribution

  • M269122270161 ()
  • 10381780248019 ()

  • 2.75 in L x 1.50 in W x .58 in H
12227016

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Tray 1 Top locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
12227007
In Commercial Distribution

  • M269122270071 ()
  • 10381780248002 ()

  • 21.15 in L x 10.62 in W x 1.80 in H
12227007

  • Instrument tray, reusable
Integra® External Fixation System The ExFix Case 1 Bottom is the portion of the case wherein system devices are placed.
Ascension Orthopedics, Inc.
12227001
In Commercial Distribution

  • M269122270011 ()
  • 10381780247982 ()

  • 21.54 in L x 10.84 in W x 4.04 in H
12227001

  • Instrument tray, reusable
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