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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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CAPTURE™ - 10381780241980

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® - 10381780247975

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® - 10381780247951

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® - 10381780247937

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® - 10381780246602

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 ™ - 10381780246534

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

Integra® - 10381780246473

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

MemoFix® Super Elastic Nitinol Staple System - 10381780246237

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

Titan™ - 10381780245858

Titan™ Reverse Shoulder System The reamer guide body inserter/extractor is used to assist with the preparation and placement of trials and implants in the reverse shoulder system.
Ascension Orthopedics, Inc.
INS096004901
In Commercial Distribution

  • M269INS0960049011 ()
  • 10381780245858 ()

  • 8.63 in L
INS-0960-049-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Titan™ - 10381780245810

Titan™ Reverse Shoulder System The stand is used as a base during stem impaction.
Ascension Orthopedics, Inc.
IMS096007001
In Commercial Distribution

  • M269IMS0960070011 ()
  • 10381780245810 ()

  • 2.2 in H
IMS-0960-070-01

  • Surgical implant/trial-implant/sizer holder, reusable
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