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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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Integra® - 10381780248163

Integra® External Fixation System The ExFix Tray 3 Top locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
12227008
In Commercial Distribution

  • M269122270081 ()
  • 10381780248163 ()

  • 21.15 in L x 10.62 in W x 2.48 in H
12227008

  • Instrument tray, reusable

Integra® - 10381780248156

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® - 10381780248033

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® - 10381780248019

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® - 10381780248002

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® - 10381780247982

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

Integra® - 10381780247920

Integra® Titanium Bone Wedge System The Titanium Foam Wedge Case is composed of a base and lid designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
CSA-1006-01
Not in Commercial Distribution

  • M269CSA1006011 ()
  • 10381780247920 ()

  • 10.26 in L x 9.62 in W x 1.30 in H
CSA100601

  • Instrument tray, reusable

Integra® - 10381780247913

Integra® Titanium Bone Wedge System The 1/2 Din Case Lid locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-000-15
In Commercial Distribution

  • M269CSA000151 ()
  • 10381780247913 ()

  • 10.54 in L x 9.91 in W x .67 in H
CSA00015

  • Instrument tray, reusable

TruArch® Subtalar Implant System - 10381780247548

Integra® TruArch® The TruArch Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
TA-7000
Not in Commercial Distribution

  • M269TA70001 ()
  • 10381780247548 ()

  • 10 in L x 10 in W x 1.5 in H
TA-7000

  • Instrument tray, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780247494

Integra® MemoFix® Staple System The MemoFix Staple Instrument Tray contains instruments used to aid in the implantation of the MemoFix Staples.
Ascension Orthopedics, Inc.
STAPLEINST
Not in Commercial Distribution

  • M269STAPLEINST1 ()
  • 10381780247494 ()

  • 10 in L x 8.5 in W x 1.75 in H
STAPLEINST

  • Instrument tray, reusable

Titan™ - 10381780247456

Titan™ Total Shoulder System The stand is used as a base during stem impaction.
Ascension Orthopedics, Inc.
SS0920054001
In Commercial Distribution

  • M269SIS09200540011 ()
  • 10381780247456 ()

  • 4.0 in L x 2.50 in W x 1.0 in H
SIS-0920-054-001

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

Integra® - 10381780247036

Integra® Total Foot System The interfrag drill guide right is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
RIGTFS18
In Commercial Distribution

  • M269RIGTFS181 ()
  • 10381780247036 ()

  • 1.3 in L x .91 in W x .75 in H
RIG-TFS-18

  • Surgical drill guide, reusable

First Choice® DRUJ System - 10381780246503

Integra® First Choice® DRUJ System DRUJ Osteotomy Guide The DRUJ (distal radioulnar joint) Osteotomy Guide attaches onto reamers and is used to determine a standard, medium, or long resection for partial resurfacing implants.
Ascension Orthopedics, Inc.
OSG610001
In Commercial Distribution

  • M269OSG6100011 ()
  • 10381780246503 ()

  • 1.82 in L x .906 in W x 1.38 in depth
OSG-610-001

  • Custom-made orthopaedic/craniofacial surgical guide

First Choice® DRUJ System - 10381780246497

Integra® First Choice® DRUJ System MUH Osteotomy Guide The Modular Ulnar Head Osteotomy Guide attaches onto reamers and is used to determine a standard, medium, or long resection.
Ascension Orthopedics, Inc.
OSG60001
In Commercial Distribution

  • M269OSG600011 ()
  • 10381780246497 ()

  • 2.09 in L x .768 in W x 1.0 in depth
OSG-600-01

  • Custom-made orthopaedic/craniofacial surgical guide

MemoFix® Super Elastic Nitinol Staple System - 10381780246312

Integra® MemoFix® Staple System The MemoFix Staple Lid is the top part of the sterilization tray which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
MT-4000L
In Commercial Distribution

  • M269MT4000L1 ()
  • 10381780246312 ()

  • 7.90 in L x 4.586 in W x .125 in H
MT-4000L

  • Instrument tray, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246305

Integra® MemoFix® Staple System The MemoFix Staple Sterilization Tray Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
MT-4000
In Commercial Distribution

  • M269MT40001 ()
  • 10381780246305 ()

  • 7.9 in L x 4.7 in W x 1.375 in H
MT-4000

  • Instrument tray, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246299

Integra® MemoFix® Staple System The MemoFix Staple Lid is the top part of the sterilization tray which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
MT-3000L
In Commercial Distribution

  • M269MT3000L1 ()
  • 10381780246299 ()

  • 10.0 in L x 8.413 in W x .125 in H
MT-3000L

  • Instrument tray, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246282

Integra® MemoFix® Staple System The Staple Sterilization Instrument Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
MT-3000
In Commercial Distribution

  • M269MT30001 ()
  • 10381780246282 ()

  • 10 in L x 8.5 in W x 1.75 in H
MT-3000

  • Instrument tray, reusable

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245544

Integra® BioMotion® Cannulated Hemi System The BioMotion Lid is the top part of the hemi sterilization tray which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
HM 7000L
In Commercial Distribution

  • M269HM7000L1 ()
  • 10381780245544 ()

  • 9.60 in L x 9.00 in W x .125 in H
HM 7000L

  • Instrument tray, reusable

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245537

Integra® BioMotion® Cannulated Hemi System The BioMotion Hemi Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
HM 7000
In Commercial Distribution

  • M269HM70001 ()
  • 10381780245537 ()

  • 9.5 in L x 9.0 in W x 2.0 in H
HM 7000

  • Instrument tray, reusable

DigiFuse® Cannulated Intramedullary Fusion System - 10381780244820

Integra® DigiFuse® The DigiFuse Lid is the top part of the sterilization tray which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
DT4500L
In Commercial Distribution

  • M269DT4500L1 ()
  • 10381780244820 ()

  • 7.90 in L x 6.0 in W x .125 in H
DT4500L

  • Instrument tray, reusable

DigiFuse® Cannulated Intramedullary Fusion System - 10381780244813

Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
DT-4500
In Commercial Distribution

  • M269DT45001 ()
  • 10381780244813 ()

  • 8.0 in L x 6.0 in W x 1.46 in H
DT-4500

  • Instrument tray, reusable

DigiFuse® Cannulated Intramedullary Fusion System - 10381780244790

Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
DT-3500
Not in Commercial Distribution

  • M269DT35001 ()
  • 10381780244790 ()

  • 8.0 in L x 6.0 in W x 1.46 in H
DT-3500

  • Instrument tray, reusable

CAPTURE™ - 10381780243694

CAPTURE™ High Torque Screw System The Capture Tray Base is the bottom portion wherein devices are placed. This base holds 7.0mm screws.
Ascension Orthopedics, Inc.
CSA-5000-007
In Commercial Distribution

  • M269CSA50000071 ()
  • 10381780243694 ()

  • 14.95 in L x 9.87 in W x 4.19 in H
CSA5000007

  • Instrument tray, reusable

Integra® - 10381780243571

Integra® Total Foot System The Rearfoot Wires, Drills, and Drill Guide Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100118
In Commercial Distribution

  • M269CSA1001181 ()
  • 10381780243571 ()

  • 9.33 in L x 7.168 in W x .125 in H
CSA-1001-18

  • Instrument tray, reusable

Integra® - 10381780243564

Integra® Total Foot System The Rearfoot Wire, Drills, and Drill Guide Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100117
In Commercial Distribution

  • M269CSA1001171 ()
  • 10381780243564 ()

  • 9.53 in L x 7.598 in W x 1.0 in H
CSA-1001-17

  • Instrument tray, reusable

Integra® - 10381780243557

Integra® Total Foot System The Rearfoot Screw Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100116
In Commercial Distribution

  • M269CSA1001161 ()
  • 10381780243557 ()

  • 7.3 in L x 5.32 in W x .125 in H
CSA-1001-16

  • Instrument tray, reusable

Integra® - 10381780243540

Integra® Total Foot System The Rearfoot Screw Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100115
In Commercial Distribution

  • M269CSA1001151 ()
  • 10381780243540 ()

  • 7.5 in L x 5.75 in W x 2.45 in H
CSA-1001-15

  • Instrument tray, reusable

Integra® - 10381780243526

Integra® Total Foot System The Rearfoot Plates Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100113
In Commercial Distribution

  • M269CSA1001131 ()
  • 10381780243526 ()

  • 11 in L x 10.6 in W x 1.0 in H
CSA-1001-13

  • Instrument tray, reusable

Integra® - 10381780243519

Integra® Total Foot System The Rearfoot Base is the bottom portion of the case which locks onto the lid and keeps content contained.
Ascension Orthopedics, Inc.
CSA100111
In Commercial Distribution

  • M269CSA1001111 ()
  • 10381780243519 ()

  • 21.2 in L x 9.9 in W x 4.09 in H
CSA-1001-11

  • Instrument tray, reusable

Integra® - 10381780243502

Integra® Total Foot System The Forefoot and Midfoot Wires, Drills, and Drill Guide Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100110
In Commercial Distribution

  • M269CSA1001101 ()
  • 10381780243502 ()

  • 9.13 in L x 6.103 in W x .125 in H
CSA-1001-10

  • Instrument tray, reusable

Integra® - 10381780243496

Integra® Total Foot System The Forefoot and Midfoot Wires, Drills, and Drill Guide Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100109
In Commercial Distribution

  • M269CSA1001091 ()
  • 10381780243496 ()

  • 9.33 in L x 6.53 in W x 1.5 in H
CSA-1001-09

  • Instrument tray, reusable

Integra® - 10381780243489

Integra® Total Foot System The Forefoot and Midfoot Screw Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100108
In Commercial Distribution

  • M269CSA1001081 ()
  • 10381780243489 ()

  • 6.3 in L x 5.32 in W x .125 in H
CSA-1001-08

  • Instrument tray, reusable

Integra® - 10381780243472

Integra® Total Foot System The Forefoot and Midfoot Plates Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100107
In Commercial Distribution

  • M269CSA1001071 ()
  • 10381780243472 ()

  • 6.5 in L x 5.75 in W x 2.33 in H
CSA-1001-07

  • Instrument tray, reusable

Integra® - 10381780243465

Integra® Total Foot System The Midfoot Plates Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100106
In Commercial Distribution

  • M269CSA1001061 ()
  • 10381780243465 ()

  • 9.13 in L x 5.07 in W x .125 in H
CSA-1001-06

  • Instrument tray, reusable

Integra® - 10381780243458

Integra® Total Foot System The Midfoot Plates Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100105
In Commercial Distribution

  • M269CSA1001051 ()
  • 10381780243458 ()

  • 9.33 in L x 5.5 in W x 1.5 in H
CSA-1001-05

  • Instrument tray, reusable

Integra® - 10381780243441

Integra® Total Foot System The Forefoot Plates Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100104
In Commercial Distribution

  • M269CSA1001041 ()
  • 10381780243441 ()

  • 9.13 in L x 5.07 in W x .125 in H
CSA-1001-04

  • Instrument tray, reusable

Integra® - 10381780243434

Integra® Total Foot System The Forefoot Plates Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA100103
In Commercial Distribution

  • M269CSA1001031 ()
  • 10381780243434 ()

  • 9.33 in L x 5.5 in W x .7 in H
CSA-1001-03

  • Instrument tray, reusable

Integra® - 10381780243427

Integra® Total Foot System The Forefoot Base Case is the bottom portion of the case which locks onto the lid and keep content contained.
Ascension Orthopedics, Inc.
CSA100101
In Commercial Distribution

  • M269CSA1001011 ()
  • 10381780243427 ()

  • 21.2 in L x 9.8 in W x 4.03 in H
CSA-1001-01

  • Instrument tray, reusable

Ascension® - 10381780243410

Integra®Surgical Instruments The MCP Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA10006
In Commercial Distribution

  • M269CSA100061 ()
  • 10381780243410 ()

  • 5.90 in L x 3.17 in W x .66 in H
CSA-100-06

  • Instrument tray, reusable

Titan™ - 10381780243380

Titan™ Reverse Shoulder System The Titan Reverse Shoulder Instrument Insert is a separate removable container in the tray that rests within the base of the case.
Ascension Orthopedics, Inc.
CSA096002
In Commercial Distribution

  • M269CSA0960021 ()
  • 10381780243380 ()

  • 20.11 in L x 9.47 in W x 2.45 in H
CSA-0960-02

  • Instrument tray, reusable

Titan™ - 10381780243373

Titan™ Reverse Shoulder System The Titan Reverse Shoulder System Instrument Set Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA096001
In Commercial Distribution

  • M269CSA0960011 ()
  • 10381780243373 ()

  • 21.2 in L x 9.8 in W x 4.47 in H
CSA-0960-01

  • Instrument tray, reusable

Titan™ - 10381780243359

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Humeral Long Stem Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA095001
In Commercial Distribution

  • M269CSA0950011 ()
  • 10381780243359 ()

  • 23.11 in L x 9.71 in W x 3.45 in H
CSA-0950-01

  • Instrument tray, reusable

Titan™ - 10381780243335

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Glenoid Instrument Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA-0923-09
In Commercial Distribution

  • M269CSA0923091 ()
  • 10381780243335 ()

  • 8.5 in L x 3.1 in W x 1.4 in H
CSA-0923-09

  • Instrument tray, reusable

Titan™ - 10381780243328

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Glenoid Instrument Tray is a container that rests within the base. It is used to contain items.
Ascension Orthopedics, Inc.
CSA-0923-08
In Commercial Distribution

  • M269CSA0923081 ()
  • 10381780243328 ()

  • 19.91 in L x 9.54 in W x 2.25 in H
CSA-0923-08

  • Instrument tray, reusable

Titan™ - 10381780243311

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Glenoid Instrument Tray Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0923-07
In Commercial Distribution

  • M269CSA0923071 ()
  • 10381780243311 ()

  • 21.84 in L x 9.8 in W x 3.79 in H
CSA-0923-07

  • Instrument tray, reusable

Titan™ - 10381780243304

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Humeral Instrument Tray 2 is a container that rests within the base. It is used to contain items.
Ascension Orthopedics, Inc.
CSA-0923-06
In Commercial Distribution

  • M269CSA0923061 ()
  • 10381780243304 ()

  • 15.88 in L x 9.54 in W x 2.6 in H
CSA-0923-06

  • Instrument tray, reusable

Titan™ - 10381780243298

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Humeral Instrument Tray 2 Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0923-05
In Commercial Distribution

  • M269CSA0923051 ()
  • 10381780243298 ()

  • 21.84 in L x 9.8 in W x 4.82 in H
CSA-0923-05

  • Instrument tray, reusable

Titan™ - 10381780243274

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Humeral Instrument Set 1 Body Trial Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA-0923-03
In Commercial Distribution

  • M269CSA0923031 ()
  • 10381780243274 ()

  • 8.95 in L x 3.39 in W x 1.27 in H
CSA-0923-03

  • Instrument tray, reusable

Titan™ - 10381780243267

Titan™ Total Shoulder SystemThe Titan Modular Total Shoulder System Humeral Instrument Tray 1 is a container that rests within the base. It is used to contain items.
Ascension Orthopedics, Inc.
CSA-0923-02
In Commercial Distribution

  • M269CSA0923021 ()
  • 10381780243267 ()

  • 19.91 in L x 9.54 in W x 2.75 in H
CSA-0923-02

  • Instrument tray, reusable
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