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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Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.
Ascension Orthopedics, Inc.
FS1040
In Commercial Distribution

  • M269FS10401 ()
  • 10381780244950 ()

  • 5.4 in L
FS1040

  • Orthopaedic inorganic implant inserter/extractor, reusable
The titanium swivel driver handle is useful for inserting small screws.
Ascension Orthopedics, Inc.
FS1005
In Commercial Distribution

  • M269FS10051 ()
  • 10381780244899 ()

  • 4.08 in L
FS1005

  • Surgical instrument handle, non-torque-limiting
Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws.
Ascension Orthopedics, Inc.
DS1007
In Commercial Distribution

  • M269DS10071 ()
  • 10381780244769 ()

  • 5.92 in L
DS1007

  • Surgical instrument handle, non-torque-limiting
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-50
Not in Commercial Distribution

  • M269DRL5010501 ()
  • 10381780244691 ()

  • 6.72 in L
DRL501050

  • Cannulated surgical drill bit, single-use
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-32
Not in Commercial Distribution

  • M269DRL5010321 ()
  • 10381780244684 ()

  • 6.72 in L
DRL501032

  • Cannulated surgical drill bit, single-use
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-1000-32
Not in Commercial Distribution

  • M269DRL1000321 ()
  • 10381780244677 ()

  • 10.21 in L
DRL100032

  • Cannulated surgical drill bit, single-use
Integra® DigiFuse® The ratchet handle is used in conjunction with the Integra DigiFuse system.
Ascension Orthopedics, Inc.
DF1500
In Commercial Distribution

  • M269DF15001 ()
  • 10381780244424 ()

  • 5.496 in L
DF1500

  • Surgical instrument handle, non-torque-limiting
Titan™ Reverse Shoulder System The stem depth stop is used with the Titan Reverse Shoulder system.
Ascension Orthopedics, Inc.
DEP096006901
In Commercial Distribution

  • M269DEP0960069011 ()
  • 10381780244417 ()

  • .76 in W
DEP-0960-069-01

  • Surgical depth gauge, reusable
Titan™ Reverse Shoulder System The double drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DDG096007701
In Commercial Distribution

  • M269DDG0960077011 ()
  • 10381780244394 ()

  • 6.00 in L
DDG-0960-077-01

  • Surgical drill guide, reusable
Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating System Countersink with AO QC is used to add space or clearance for the head of a screw being placed in the bone.
Ascension Orthopedics, Inc.
CSK-5010-01
Not in Commercial Distribution

  • M269CSK5010011 ()
  • 10381780244226 ()

  • 4.75 in L
CSK501001

  • Surgical screwdriver, reusable
Integra® Silicone PIP Starter Awl The Starter Awl is used to penetrate the articular surface and expose the canal of the metacarpal and phalangeal bone.
Ascension Orthopedics, Inc.
AWL-520-01
In Commercial Distribution

  • M269AWL520011 ()
  • 10381780242178 ()

  • 7.53 in L
AWL-520-01

  • Orthopaedic knife
The Stem Trial is used to verify proper implant placement and sizing.
Ascension Orthopedics, Inc.
TRL31004
In Commercial Distribution

  • M269TRL310041 ()
  • 10381780236269 ()

  • .289 in dia
TRL-310-04

  • Elbow radius prosthesis trial
The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in prepared cavities. The trial evaluates joint articulation and ligament tension.
Ascension Orthopedics, Inc.
TRL-101-50P
In Commercial Distribution

  • M269TRL10150P1 ()
  • 10381780236146 ()

  • 1.620 in L


  • Surgical implant template, reusable
Ascension® MCP Proximal Metal Trial Size 40
Ascension Orthopedics, Inc.
TRL10140P
In Commercial Distribution

  • M269TRL10140P1 ()
  • 10381780236122 ()

  • 1.447 in L
TRL-101-40P

  • Surgical implant template, reusable
Ascension® MCP Proximal Metal Trial Size 30
Ascension Orthopedics, Inc.
TRL10130P
In Commercial Distribution

  • M269TRL10130P1 ()
  • 10381780236108 ()

  • 1.275 in L
TRL-101-30P

  • Surgical implant template, reusable
Ascension® MCP Proximal Metal Trial Size 20
Ascension Orthopedics, Inc.
TRL10120P
In Commercial Distribution

  • M269TRL10120P1 ()
  • 10381780236085 ()

  • 1.103 in L
TRL-101-20P

  • Surgical implant template, reusable
Ascension® MCP Proximal Metal Trial Size 10
Ascension Orthopedics, Inc.
TRL10110P
In Commercial Distribution

  • M269TRL10110P1 ()
  • 10381780236061 ()

  • .936 in L
TRL-101-10P

  • Surgical implant template, reusable
Ascension® MCP Proximal Metal Trial Size 05
Ascension Orthopedics, Inc.
TRL10105P
In Commercial Distribution

  • M269TRL10105P1 ()
  • 10381780236047 ()

  • .806 in L
TRL-101-05P

  • Surgical implant template, reusable
TSS Fracture Hum Implant Inserter/Extractor
Ascension Orthopedics, Inc.
IS0950045001
In Commercial Distribution

  • M269IS09500450011 ()
  • 10381780237136 ()

  • 8.6 in L
INS-0950-045-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral body inserter/extractor knob is used to tighten or loosen the inserter/extractor.
Ascension Orthopedics, Inc.
INS096004802
Not in Commercial Distribution

  • M269INS0960048021 ()
  • 10381780237129 ()

  • 1.5 in L


  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral body inserter/extractor is used to insert the implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS096004801
In Commercial Distribution

  • M269INS0960048011 ()
  • 10381780237112 ()

  • 8.36 in L
INS-0960-048-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
The glenosphere inserter is used to insert the glenosphere into the baseplate.
Ascension Orthopedics, Inc.
HDL096006501
In Commercial Distribution

  • M269HDL0960065011 ()
  • 10381780237051 ()

  • 9.8 in L
HDL-0960-065-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
Titan™ Total Shoulder System Starter Awl 6mm The Starter Awl is used to penetrate the articular surface and expose the canal.
Ascension Orthopedics, Inc.
AL0920042001
In Commercial Distribution

  • M269AWL09200420011 ()
  • 10381780242147 ()

  • 12.5 in L
AWL-0920-042-001

  • Orthopaedic knife
CAPTURE™ Cannulated Screw System The TQ 3 Prong Driver Shaft is cannulated to accept the QuickSnap screw shank. It has 3 prongs that grasp the slots of both the screw shank as well as the screw head.
Ascension Orthopedics, Inc.
AI-5010
In Commercial Distribution

  • M269AI50101 ()
  • 10381780241997 ()

  • 3.13 in L
AI5010

  • Surgical screwdriver, reusable
CAPTURE™ Cannulated Screw System The solid removal driver is used in conjunction with the TH-series screws.
Ascension Orthopedics, Inc.
AI-4040
In Commercial Distribution

  • M269AI40401 ()
  • 10381780241980 ()

  • 2.56 in L
AI4040

  • Surgical screwdriver, reusable
CAPTURE™ Cannulated Screw System The TH cannulated depth gauge is used to measure the depth of a drilled hole.
Ascension Orthopedics, Inc.
AI-4020
In Commercial Distribution

  • M269AI40201 ()
  • 10381780241966 ()

  • 4.16 in L
AI4020

  • Surgical depth gauge, reusable
CAPTURE™ Cannulated Screw SystemThe cannulated driver is used in conjunction with the TH-series screws.
Ascension Orthopedics, Inc.
AI-4010
In Commercial Distribution

  • M269AI40101 ()
  • 10381780241959 ()

  • 2.56 in L
AI4010

  • Surgical screwdriver, reusable
CAPTURE™ Cannulated Screw System The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with the TC-series 3.0/4.0mm screws.
Ascension Orthopedics, Inc.
AI-3040
In Commercial Distribution

  • M269AI30401 ()
  • 10381780241881 ()

  • 6.86 in L
AI3040

  • Surgical depth gauge, reusable
CAPTURE™ Cannulated Screw System The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with the TC-series 2.0/2.5mm screws.
Ascension Orthopedics, Inc.
AI-3030
In Commercial Distribution

  • M269AI30301 ()
  • 10381780241874 ()

  • 6.19 in L
AI3030

  • Surgical depth gauge, reusable
CAPTURE™ Cannulated Screw System The screw removal instrument is used in conjunction with the Capture Cannulated Screw System.
Ascension Orthopedics, Inc.
AI-1040
In Commercial Distribution

  • M269AI10401 ()
  • 10381780241829 ()

  • 5.4 in L
AI-1040

  • Surgical implant handling forceps
CAPTURE™ Cannulated Screw System The ratchet handle is used in conjunction with the Capture Cannulated Screw System.
Ascension Orthopedics, Inc.
AI-1006
In Commercial Distribution

  • M269AI10061 ()
  • 10381780241805 ()

  • 5.9 in L
AI1006

  • Surgical instrument handle, non-torque-limiting
Titan™ Total Shoulder System The Taper Adapter allows for preparation and retraction of the humerus for glenoid preparation.
Ascension Orthopedics, Inc.
ADT-0923-065-001
In Commercial Distribution

  • M269ADT09230650011 ()
  • 10381780241775 ()

  • .765 in L
ADT-0923-065-001

  • Orthopaedic implant/instrument assembling device
CAPTURE™ Cannulated Screw System The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with the DS-series screws.
Ascension Orthopedics, Inc.
AD-1008
In Commercial Distribution

  • M269AD10081 ()
  • 10381780241690 ()

  • 5.0 in L
AD-1008

  • Surgical depth gauge, reusable
CAPTURE™ Cannulated Screw System The forceps are used for screw pickup in the Capture Cannulated Screw System.
Ascension Orthopedics, Inc.
AI-1030
In Commercial Distribution

  • M269AI10301 ()
  • 10381780241812 ()

  • 3.5 in L
AI1030

  • Surgical implant handling forceps
The Integra External Fixation System half pin caps are added to cover the cut end of the half pins.
Ascension Orthopedics, Inc.
12224207
In Commercial Distribution

  • 10381780125105 ()

  • .50 in H
12224207

  • External orthopaedic fixation system, reusable
The humeral trial inserter/extractor is used to insert the trial implant into its place, as well as extract.
Ascension Orthopedics, Inc.
IS0950046001
In Commercial Distribution

  • M269INS09500460011 ()
  • 10381780124696 ()

  • 8.3 in L
INS-0950-046-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral trial inserter/extractor is used to insert the trial implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS-0923-046-001
In Commercial Distribution

  • M269INS09230460011 ()
  • 10381780124689 ()

  • 8.4 in L
INS-0923-046-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral implant inserter/extractor is used to insert the implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS-0923-045-001
In Commercial Distribution

  • M269INS09230450011 ()
  • 10381780124672 ()

  • 8.5 in L
INS-0923-045-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral trial inserter/extractor is used to insert the trial implant into its place, as well as extract.
Ascension Orthopedics, Inc.
IS0920046001
In Commercial Distribution

  • M269INS09200460011 ()
  • 10381780124665 ()

  • 8.3 in L
INS-0920-046-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral implant inserter/extractor is used to insert the implant into its place, as well as extract.
Ascension Orthopedics, Inc.
IS0920045001
In Commercial Distribution

  • M269INS09200450011 ()
  • 10381780124658 ()

  • 8.6 in L
INS-0920-045-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070002E
In Commercial Distribution

  • M269HSP0920070002E1 ()
  • 10381780124504 ()

  • 1.575 in dia


  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070001E
In Commercial Distribution

  • M269HSP0920070001E1 ()
  • 10381780124498 ()

  • 1.469 in dia


  • Surgical implant template, reusable
The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable
The Integra External Fixation System three-hole plate is manufactured from stainless steel. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224217
In Commercial Distribution

  • 10381780125327 ()

  • 2.72 in L
12224217

  • External orthopaedic fixation system, reusable
The four hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224225
In Commercial Distribution

  • 10381780125204 ()

  • 2.226 in H
12224225

  • External orthopaedic fixation system, reusable
The three hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224224
In Commercial Distribution

  • 10381780125198 ()

  • 1.725 in H
12224224

  • External orthopaedic fixation system, reusable
The two hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224223
In Commercial Distribution

  • 10381780125181 ()

  • 1.223 in H
12224223

  • External orthopaedic fixation system, reusable
The one hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224222
In Commercial Distribution

  • 10381780125174 ()

  • .722 in H
12224222

  • External orthopaedic fixation system, reusable
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
513NS
In Commercial Distribution

  • M665513NS1 ()
  • M665513NS0 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.4375 Inch
  • Wall: 0.09375 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
512NS
In Commercial Distribution

  • M665512NS0 ()
  • M665512NS1 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.5 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
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