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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Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. XL The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059004
In Commercial Distribution

  • M269RMR09200590041 ()
  • 10381780247159 ()

  • Size XL; 1.0 in L x 1.55 in dia
RMR-0920-059-004

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. L The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059003
In Commercial Distribution

  • M269RMR09200590031 ()
  • 10381780247142 ()

  • Size L; 1.0 in L x 1.55 in dia
RMR-0920-059-003

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. M The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059002
In Commercial Distribution

  • M269RMR09200590021 ()
  • 10381780247135 ()

  • Size M; 1.0 in L x 1.45 in dia
RMR-0920-059-002

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. S The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059001
In Commercial Distribution

  • M269RMR09200590011 ()
  • 10381780247128 ()

  • Size S; 1.0 in L x 1.35 in dia
RMR-0920-059-001

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. XS The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059000
In Commercial Distribution

  • M269RMR09200590001 ()
  • 10381780247111 ()

  • Size XS; 1.0 in L x 1.25 in dia
RMR-0920-059-000

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System Glenoid Reamer Large The glenoid reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920057003
In Commercial Distribution

  • M269RMR09200570031 ()
  • 10381780247104 ()

  • Size L; 1.33 in L x 1.55 in dia
RMR-0920-057-003

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System Glenoid Reamer Medium The glenoid reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920057002
In Commercial Distribution

  • M269RMR09200570021 ()
  • 10381780247098 ()

  • Size M; 1.33 in L x 1.45 in dia
RMR-0920-057-002

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System Glenoid Reamer Small The glenoid reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920057001
In Commercial Distribution

  • M269RMR09200570011 ()
  • 10381780247081 ()

  • Size S; 1.31 in L x 1.35 in dia
RMR-0920-057-001

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System Glenoid Reamer Extra Small The glenoid reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920057000
In Commercial Distribution

  • M269RMR09200570001 ()
  • 10381780247074 ()

  • Size XS; 1.31 in L x 1.25 in dia
RMR-0920-057-000

  • Bone-resection orthopaedic reamer, reusable
Integra®Surgical Instruments The Darrach Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET-920-11S
In Commercial Distribution

  • M269RET92011S1 ()
  • 10381780246831 ()

  • Size 01; 10.7 in L x .50 in W
RET-920-11S

  • Hand-held surgical retractor, reusable
Integra®Surgical Instruments The Darrach Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET-920-11L
In Commercial Distribution

  • M269RET92011L1 ()
  • 10381780246824 ()

  • Size 02; 10.7 in L x .75 in W
RET-920-11L

  • Hand-held surgical retractor, reusable
Titan™ Humeral Resurfacing Arthroplasty The Darrach Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET92010S
In Commercial Distribution

  • M269RET92010S1 ()
  • 10381780246817 ()

  • Size 01; 10.7 in L x .50 in W
RET-920-10S

  • Hand-held surgical retractor, reusable
Titan™ Humeral Resurfacing Arthroplasty The Darrach Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET92010L
In Commercial Distribution

  • M269RET92010L1 ()
  • 10381780246800 ()

  • Size 02; 10.7 in L x .75 in W
RET-920-10L

  • Hand-held surgical retractor, reusable
PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 40
Ascension Orthopedics, Inc.
OSG20040PV
In Commercial Distribution

  • M269OSG20040PV1 ()
  • 10381780246459 ()

  • Size 40; 1.215 in L x 1.127 in W
OSG-200-40PV

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Prox, Cut Guide, Volar Appr, Sz 30
Ascension Orthopedics, Inc.
OSG20030PV
In Commercial Distribution

  • M269OSG20030PV1 ()
  • 10381780246435 ()

  • Size 30; 1.108 in L x 1.087 in W
OSG-200-30PV

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 20
Ascension Orthopedics, Inc.
OSG20020PV
In Commercial Distribution

  • M269OSG20020PV1 ()
  • 10381780246411 ()

  • Size 20; 1.061 in L x 1.047 in W
OSG-200-20PV

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 10
Ascension Orthopedics, Inc.
OSG20010PV
In Commercial Distribution

  • M269OSG20010PV1 ()
  • 10381780246398 ()

  • Size 10; 1.015 in L x 1.007 in W
OSG-200-10PV

  • Custom-made orthopaedic/craniofacial surgical guide
Modular Radial Head MRH Reamer Sz. 03
Ascension Orthopedics, Inc.
MRHRMR03
In Commercial Distribution

  • M269MRHRMR031 ()
  • 10381780246053 ()

  • Size 03; 6.27 in L x 2.36 in W
MRH-RMR-03

  • Bone-resection orthopaedic reamer, reusable
Modular Radial Head MRH Reamer Sz. 02
Ascension Orthopedics, Inc.
MRHRMR02
In Commercial Distribution

  • M269MRHRMR021 ()
  • 10381780246046 ()

  • Size 02; 6.34 in L x 2.36 in W
MRH-RMR-02

  • Bone-resection orthopaedic reamer, reusable
Modular Radial Head MRH Reamer Sz. 01
Ascension Orthopedics, Inc.
MRHRMR01
In Commercial Distribution

  • M269MRHRMR011 ()
  • 10381780246039 ()

  • Size 01; 6.4 in L x 2.36 in W
MRH-RMR-01

  • Bone-resection orthopaedic reamer, reusable
Integra® Ti6® The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with the Ti6 Digital Screw.
Ascension Orthopedics, Inc.
DS1008
In Commercial Distribution

  • M269DS10081 ()
  • 10381780244776 ()

  • 3.42 in L x .112 in center dia tip
DS1008

  • Surgical depth gauge, reusable
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44340M
In Commercial Distribution

  • M269TRL44340M1 ()
  • 10381780236580 ()

  • .465 in L head x .858 in L stem
TRL-443-40M

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44340L
In Commercial Distribution

  • M269TRL44340L1 ()
  • 10381780236573 ()

  • .517 in L head x .858 in L stem
TRL-443-40L

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44330S
In Commercial Distribution

  • M269TRL44330S1 ()
  • 10381780236566 ()

  • .399 in L head x .796 in L stem
TRL-443-30S

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44330M
In Commercial Distribution

  • M269TRL44330M1 ()
  • 10381780236559 ()

  • .465 in L head x .796 in L stem
TRL-443-30M

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44330L
In Commercial Distribution

  • M269TRL44330L1 ()
  • 10381780236542 ()

  • .517 in L head x .796 in L stem
TRL-443-30L

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44320S
In Commercial Distribution

  • M269TRL44320S1 ()
  • 10381780236535 ()

  • .399 in L head x .682 in L stem
TRL-443-20S

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44320M
In Commercial Distribution

  • M269TRL44320M1 ()
  • 10381780236528 ()

  • .465 in L head x .682 in L stem
TRL-443-20M

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44310S
In Commercial Distribution

  • M269TRL44310S1 ()
  • 10381780236511 ()

  • .399 in L head x .620 in L stem
TRL-443-10S

  • Carpometacarpal interpositional spacer prosthesis trial
The NuGrip Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL44310M
In Commercial Distribution

  • M269TRL44310M1 ()
  • 10381780236504 ()

  • .465 in L head x .620 in L stem
TRL-443-10M

  • Carpometacarpal interpositional spacer prosthesis trial
CAPTURE™ Cannulated Screw System The driver is used in conjunction with the TC-series 3.0/4.0mm screws.
Ascension Orthopedics, Inc.
AI-3020
In Commercial Distribution

  • M269AI30201 ()
  • 10381780241850 ()

  • 4.40 in L x .103 in dia driver shaft
AI3020

  • Surgical screwdriver, reusable
CAPTURE™ Cannulated Screw System The driver is used in conjunction with the TC-series 2.0/2.5mm screws.
Ascension Orthopedics, Inc.
AI-3010
In Commercial Distribution

  • M269AI30101 ()
  • 10381780241843 ()

  • 3.46 in L x .103 in dia driver shaft
AI3010

  • Surgical screwdriver, reusable
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012016
Not in Commercial Distribution

  • M2480120161 ()
  • 10381780065487 ()

  • .816 in dia x .662 in L; Size 3
012016

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012014
Not in Commercial Distribution

  • M2480120141 ()
  • 10381780065470 ()

  • .776 in dia x .662 in L; Size 2
012014

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012012
Not in Commercial Distribution

  • M2480120121 ()
  • 10381780065463 ()

  • .734 in dia x .662 in L; Size 1
012012

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012010
Not in Commercial Distribution

  • M2480120101 ()
  • 10381780065456 ()

  • .672 in dia x .662 in L; Size 0
012010

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012007
Not in Commercial Distribution

  • M2480120071 ()
  • 10381780065449 ()

  • .93 in L x .759 in W; Size 3
012007

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012006
Not in Commercial Distribution

  • M2480120061 ()
  • 10381780065432 ()

  • .93 in L x .759 in W; Size 3
012006

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012005
Not in Commercial Distribution

  • M2480120051 ()
  • 10381780065425 ()

  • .89 in L x .733 in W; Size 2
012005

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012004
Not in Commercial Distribution

  • M2480120041 ()
  • 10381780065418 ()

  • .89 in L x .733 in W; Size 2
012004

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012003
Not in Commercial Distribution

  • M2480120031 ()
  • 10381780065401 ()

  • .85 in L x .696 in W; Size 1
012003

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012002
Not in Commercial Distribution

  • M2480120021 ()
  • 10381780065395 ()

  • .85 in L x .696 in W; Size 1
012002

  • Partial metatarsophalangeal joint prosthesis
The Universal Wire Fixation Bolts are used to connect the wires to the rings. They are made from stainless steel.
Ascension Orthopedics, Inc.
12224218
In Commercial Distribution

  • 10381780125143 ()

  • .93 in L x .410 in full thread L
12224218

  • External orthopaedic fixation system, reusable
Cannulated screw is a machined, metallic screw that is manufactured from stainless steel and titanium with a cannulation that is self-drilling and self-tapping. The CAPTURE High-Torque Screw is intended for fixation of the pelvis and illiosacral join, as well as fixations of fractures and osteotomies in long and small bones, including those in the foot, patella, ankle, wrist, and elbow. Intended for use correction Arthrodesis of the foot, wrist and elbow.
Ascension Orthopedics, Inc.
CSS500000170105T
In Commercial Distribution

  • M269CSS500000170105T1 ()
  • 10381780122036 ()

  • 4.134 in L x .276 in Dia; 1.38 Thread
CSS500000170105T

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002514
In Commercial Distribution

  • 10381780120643 ()
  • M268STEM0950025141 ()

  • 3.86 in L x .550 in dia; Size 14
STEM-0950-025-14

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002512
In Commercial Distribution

  • 10381780120636 ()
  • M268STEM0950025121 ()

  • 3.86 in L x .470 in dia; Size 12
STEM-0950-025-12

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002510
In Commercial Distribution

  • 10381780120629 ()
  • M268STEM0950025101 ()

  • 3.86 in L x .390 in dia; Size 10
STEM-0950-025-10

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation.
Ascension Orthopedics, Inc.
SEM092002516
In Commercial Distribution

  • 10381780120599 ()
  • M268STEM0920025161 ()

  • 3.86 in L x .686 in dia; Size 16
STEM-0920-025-16

  • Press-fit shoulder humeral stem prosthesis
The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation.
Ascension Orthopedics, Inc.
SEM092002513
In Commercial Distribution

  • 10381780120568 ()
  • M268STEM0920025131 ()

  • 3.86 in L x .560 in dia; Size 13
STEM-0920-025-13

  • Press-fit shoulder humeral stem prosthesis
The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation.
Ascension Orthopedics, Inc.
SEM092002511
In Commercial Distribution

  • 10381780120544 ()
  • M268STEM0920025111 ()

  • 3.86 in L x .475 in dia; Size 11
STEM-0920-025-11

  • Press-fit shoulder humeral stem prosthesis
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