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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 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
Integra® External Fixation System The k-wire guide is used during strut assembly in the external fixation system.
Ascension Orthopedics, Inc.
12225315
In Commercial Distribution

  • M269122253151 ()
  • 10381780247975 ()

  • 2.56 in L
12225315

  • Orthopaedic guidewire, reusable
Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-04
Not in Commercial Distribution

  • M269CSA1006041 ()
  • 10381780247951 ()

  • 6.625 in L
CSA100604

  • Instrument tray, reusable
Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-02
Not in Commercial Distribution

  • M269CSA1006021 ()
  • 10381780247937 ()

  • 6.625 in L
CSA100602

  • Instrument tray, reusable
Construct® Ankle Fusion Plate System The PF pin with AO quick connect is used for temporary fixation.
Ascension Orthopedics, Inc.
PFP-5010-32
Not in Commercial Distribution

  • M269PFP5010321 ()
  • 10381780246602 ()

  • 3.46 in L
PFP-5010-32

  • Orthopaedic implant aiming arm
Construct® Ankle Fusion Plate System The Plate Bending Handles are used to bend pre-countored plates to match specific patient anatomy.
Ascension Orthopedics, Inc.
PBH-5010-01
Not in Commercial Distribution

  • M269PBH5010011 ()
  • 10381780246534 ()

  • 7.78 in L
PBH501001

  • Manual orthopaedic bender, reusable
Silicone PIP Cut Guide
Ascension Orthopedics, Inc.
OSG44200
In Commercial Distribution

  • M269OSG442001 ()
  • 10381780246473 ()

  • 2.39 in L
OSG-442-00

  • Custom-made orthopaedic/craniofacial surgical guide
Integra® MemoFix® Staple System The MemoFix tamp is used to push down the staple into the bone.
Ascension Orthopedics, Inc.
MS-2920
In Commercial Distribution

  • M269MS29201 ()
  • 10381780246237 ()

  • 6.02 in L
MS-2920

  • Surgical tamp, reusable
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