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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™ - 10381780235552

The Eccentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-3814E
In Commercial Distribution

  • M269TRL09230103814E1 ()
  • 10381780235552 ()

  • 1.5 in dia x .551 in H
TRL-0923-010-3814E

  • Humeral head prosthesis trial, reusable

Integra® - 10381780242154

Surgical Instruments Starter Awl
Ascension Orthopedics, Inc.
AWL10001
In Commercial Distribution

  • M269AWL100011 ()
  • 10381780242154 ()

  • 3.26 in L x .118 in dia
AWL-100-01

  • Orthopaedic knife

CAPTURE™ - 10381780242093

CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1111
In Commercial Distribution

  • M269AW11111 ()
  • 10381780242093 ()

  • 3.53 in L x .0315 in dia
AW1111

  • Orthopaedic guidewire, reusable

CAPTURE™ - 10381780242062

CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1103
In Commercial Distribution

  • M269AW11031 ()
  • 10381780242062 ()

  • 4.75 in L x .0433 in dia
AW1103

  • Orthopaedic guidewire, reusable

CAPTURE™ - 10381780242055

CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1102
In Commercial Distribution

  • M269AW11021 ()
  • 10381780242055 ()

  • 3.95 in L x .035 in dia
AW1102

  • Orthopaedic guidewire, reusable

Movement® - 10381780242048

Movement® Great Toe System The sizer alignment guide is used with the Movement Great Toe system.
Ascension Orthopedics, Inc.
ALG-890-00
In Commercial Distribution

  • M269ALG890001 ()
  • 10381780242048 ()

  • 3.25 in L x .13 in dia
ALG89000

  • Orthopaedic implant aiming arm

Integra® - 10381780242031

Surgical Instruments Alignment Guide
Ascension Orthopedics, Inc.
ALG10000
In Commercial Distribution

  • M269ALG100001 ()
  • 10381780242031 ()

  • 4.5 in L; 3.25 in L rod
ALG-100-00

  • Orthopaedic implant aiming arm

Integra® - 10381780248187

Integra® External Fixation System The punch is used for the half pin drill guide in the external fixation system.
Ascension Orthopedics, Inc.
12225020002
In Commercial Distribution

  • M269122250200021 ()
  • 10381780248187 ()

  • 5.245 in L x .176 in dia
12225020002

  • Surgical drill guide, reusable

Integra® - 10381780247999

Integra® External Fixation System The generic lid is the top part of the case which locks onto the base and keeps content inside.
Ascension Orthopedics, Inc.
12227006
In Commercial Distribution

  • M269122270061 ()
  • 10381780247999 ()

  • 21.61 in L x 11.10 in W
12227006

  • Instrument tray, reusable

Integra® - 10381780247968

Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-05
Not in Commercial Distribution

  • M269CSA1006051 ()
  • 10381780247968 ()

  • 6.584 in L x 3.19 in W
CSA100605

  • Instrument tray, reusable

Integra® - 10381780247944

Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-03
Not in Commercial Distribution

  • M269CSA1006031 ()
  • 10381780247944 ()

  • 6.584 in L x 5.215 in W
CSA100603

  • Instrument tray, reusable

Titan™ - 10381780247555

Titan™ Total Shoulder System The taper disassembly tool is used in the total shoulder system.
Ascension Orthopedics, Inc.
TT0920044001
In Commercial Distribution

  • M269TDT09200440011 ()
  • 10381780247555 ()

  • 4.0 in L x 1.0 in H
TDT-0920-044-001

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780247500

Titan™ Total Shoulder System The stand is used as a base during head impaction.
Ascension Orthopedics, Inc.
SD0920071001
In Commercial Distribution

  • M269STD09200710011 ()
  • 10381780247500 ()

  • 5.16 in L x 4.26 in H
STD-0920-071-001

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

Integra® - 10381780246619

Integra®Surgical Instruments The fixation pin helps with stabilization.
Ascension Orthopedics, Inc.
PN0920051001
In Commercial Distribution

  • M269PIN09200510011 ()
  • 10381780246619 ()

  • 4.0 in L x .094 in dia
PIN-0920-051-001

  • Orthopaedic guidewire, reusable

Titan™ - 10381780246596

Titan™ Reverse Shoulder System The anti-rotation baseplate peg is used to maintain baseplate orientation.
Ascension Orthopedics, Inc.
PEG096007301
In Commercial Distribution

  • M269PEG0960073011 ()
  • 10381780246596 ()

  • .79 in L x .307 in dia
PEG-0960-073-01

  • Orthopaedic implant aiming arm

Integra® - 10381780246343

Integra®Surgical Instruments The ratchet t-handle is provided with quick connect.
Ascension Orthopedics, Inc.
NR135004J004
In Commercial Distribution

  • M269NR135004J0041 ()
  • 10381780246343 ()

  • 4.5 in L x 3.88 in W
NR135004-J-004

  • Surgical instrument handle, non-torque-limiting

Integra® - 10381780245988

Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone.
Ascension Orthopedics, Inc.
MAL092008501
In Commercial Distribution

  • M269MAL0920085011 ()
  • 10381780245988 ()

  • 8.7 in L x 2.5 in W
MAL-0920-085-01

  • Orthopaedic implant impactor, reusable

Integra® - 10381780245971

Integra®Total Foot System The interfrag drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
LIGTFS18
In Commercial Distribution

  • M269LIGTFS181 ()
  • 10381780245971 ()

  • 1.3 in L x .91 in W
LIG-TFS-18

  • Surgical drill guide, reusable

Construct ™ - 10381780245940

Construct® Ankle Fusion Plate System The locking drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
LDG-5010-65
Not in Commercial Distribution

  • M269LDG5010651 ()
  • 10381780245940 ()

  • 2.166 in L x .201 in dia
LDG501065

  • Surgical drill guide, reusable

First Choice® DRUJ System - 10381780245773

Integra® First Choice® DRUJ System MUH Back Table Assy Pad The back table assembly plate is used to compare resected heads to the closest implant head size.
Ascension Orthopedics, Inc.
IMP60001
In Commercial Distribution

  • M269IMP600011 ()
  • 10381780245773 ()

  • 3.0 in dia x 1.0 in depth
IMP-600-01

  • Orthopaedic implant/instrument assembling device

Integra® - 10381780245742

Modular Radial Head Back Table Assembly Pad, MRH
Ascension Orthopedics, Inc.
IMP35001
In Commercial Distribution

  • M269IMP350011 ()
  • 10381780245742 ()

  • 3.0 in dia x 1.0 in depth
IMP-350-01

  • Orthopaedic implant/instrument assembling device

Integra® - 10381780245728

Surgical Instruments Implant Impactor
Ascension Orthopedics, Inc.
IMP30000
In Commercial Distribution

  • M269IMP300001 ()
  • 10381780245728 ()

  • 3.83 in L x 1.0 in W
IMP-300-00

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245582

Titan™ Total Shoulder System The head sizing gauge 48-52 is used to measure the resected head diameter and thickness.
Ascension Orthopedics, Inc.
HG0920041002
In Commercial Distribution

  • M269HSG09200410021 ()
  • 10381780245582 ()

  • 10.0 in L x 2.0 in W
HSG-0920-041-002

  • Surgical depth gauge, reusable

Titan™ - 10381780245575

Titan™ Total Shoulder System The head sizing gauge 38-46 is used to measure the resected head diameter and thickness.
Ascension Orthopedics, Inc.
HG0920041001
In Commercial Distribution

  • M269HSG09200410011 ()
  • 10381780245575 ()

  • 10.0 in L x 2.0 in W
HSG-0920-041-001

  • Surgical depth gauge, reusable

Construct ™ - 10381780245384

Construct® Ankle Fusion Plate System The right guide pin targeting base is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-02
Not in Commercial Distribution

  • M269GTB1000021 ()
  • 10381780245384 ()

  • 3.18 in L x 2.73 in W
GTB100002

  • Orthopaedic guidewire, reusable

Construct ™ - 10381780245377

Construct® Ankle Fusion Plate System The left guide pin targeting base is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-01
Not in Commercial Distribution

  • M269GTB1000011 ()
  • 10381780245377 ()

  • 3.18 in L x 2.73 in W
GTB100001

  • Orthopaedic guidewire, reusable

Integra® - 10381780245247

Surgical Instruments Slotted Mallet
Ascension Orthopedics, Inc.
G107991B
In Commercial Distribution

  • 10381780245247 ()

  • 8.7 in L x 2.5 in W
  • Length: 8.7 Inch
  • Width: 2.5 Inch
G107991B

  • Surgical instrument handle, non-torque-limiting

DigiFuse® Cannulated Intramedullary Fusion System - 10381780244844

Integra® DigiFuse® The smooth guide wire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
DW-2590
In Commercial Distribution

  • M269DW25901 ()
  • 10381780244844 ()

  • 2.756 in L x .031 in dia
DW-2590

  • Orthopaedic guidewire, reusable

Movement® - 10381780244387

Movement® Great Toe System The Metatarsal Dorsal Cut Guide allows for precise cheilectomy of dorsal osteophytes when implanting the metatarsal component.
Ascension Orthopedics, Inc.
DCG-890-00
In Commercial Distribution

  • M269DCG890001 ()
  • 10381780244387 ()

  • 7.0 in L x .216 in dia
DCG89000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPTURE™ - 10381780243670

CAPTURE™ High Torque Screw System The Capture 7.0mm Screw Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-5000-005
In Commercial Distribution

  • M269CSA50000051 ()
  • 10381780243670 ()

  • 8.53 in L x 7.45 in W
CSA5000005

  • Instrument tray, reusable

CAPTURE™ - 10381780243663

CAPTURE™ High Torque Screw System The Capture 7.0mm Screw Caddy is a smaller, removable container that rests within the Base or Insert.
Ascension Orthopedics, Inc.
CSA-5000-004
In Commercial Distribution

  • M269CSA50000041 ()
  • 10381780243663 ()

  • 7.75 in L x 7.46 in W
CSA5000004

  • Instrument tray, reusable

Integra® - 10381780243533

Integra® Total Foot System The Rearfoot Plates Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA100114
In Commercial Distribution

  • M269CSA1001141 ()
  • 10381780243533 ()

  • 10.57 in L x 9.33 in W
CSA-1001-14

  • Instrument tray, reusable

Titan™ - 10381780243366

Titan™ Total Shoulder System The Titan Modular Total Shoulder System Humeral Long Stem Inset Tray 1 is a container that rests within the base. It is used to contain items.
Ascension Orthopedics, Inc.
CSA095002
In Commercial Distribution

  • M269CSA0950021 ()
  • 10381780243366 ()

  • 19.85 in L x 1.88 in H
CSA-0950-02

  • Instrument tray, reusable

Titan™ - 10381780243281

Titan™ Total Shoulder System The Titan Total Shoulder Humeral Instrument Set 1 Body Trial Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-0923-04
In Commercial Distribution

  • M269CSA0923041 ()
  • 10381780243281 ()

  • 8.92 in L x 3.08 in W
CSA-0923-04

  • Instrument tray, reusable

Titan™ - 10381780243243

Titan™ Total Shoulder System The Titan Total Shoulder Glenoid Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA092026
In Commercial Distribution

  • M269CSA0920261 ()
  • 10381780243243 ()

  • 7.92 in L x 2.89 in W
CSA-0920-26

  • Instrument tray, reusable

Titan™ - 10381780243182

Titan™ Total Shoulder System The Titan Total Shoulder Humeral Instrument Set 1 Taper Adapter Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA092020
In Commercial Distribution

  • M269CSA0920201 ()
  • 10381780243182 ()

  • 2.07 in L x 2.0 in W
CSA-0920-20

  • Instrument tray, reusable

Titan™ - 10381780243168

Titan™ Total Shoulder System The Titan Total Shoulder Humeral Instrument Set 1 Proximal Trial Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA092018
In Commercial Distribution

  • M269CSA0920181 ()
  • 10381780243168 ()

  • 8.92 in L x 3.08 in W
CSA-0920-18

  • Instrument tray, reusable

TruArch® Subtalar Implant System - 10381780247869

Integra® TruArch® The guide wire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
TW-1100
Not in Commercial Distribution

  • M269TW11001 ()
  • 10381780247869 ()

  • 9.0 in L x .063 in dia
TW-1100

  • Orthopaedic guidewire, reusable

Titan™ - 10381780247449

Titan™ Total Shoulder System The version rod is used in the total shoulder system.
Ascension Orthopedics, Inc.
SET189D007
In Commercial Distribution

  • M269SET189D0071 ()
  • 10381780247449 ()

  • 6.0 in L x .095 in W
SET189-D007

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780247302

Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
ROD-0923-040-001
In Commercial Distribution

  • M269ROD09230400011 ()
  • 10381780247302 ()

  • 6.23 in L x .19 in dia
ROD-0923-040-001

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780247296

Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
RD0920040002
In Commercial Distribution

  • M269ROD09200400021 ()
  • 10381780247296 ()

  • 6.23 in L x .19 in dia
ROD-0920-040-002

  • Surgical instrument handle, non-torque-limiting

Integra® - 10381780246862

Integra®Surgical Instruments The Hohman Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET-920-31
In Commercial Distribution

  • M269RET920311 ()
  • 10381780246862 ()

  • 8.9 in L x 4.5 in W
RET-920-31

  • Hand-held surgical retractor, reusable

Integra® - 10381780246855

Integra®Surgical Instruments The Hohman Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET92030
In Commercial Distribution

  • M269RET920301 ()
  • 10381780246855 ()

  • 8.9 in L x 4.5 in W
RET-920-30

  • Hand-held surgical retractor, reusable

Integra® - 10381780246848

Integra®Surgical Instruments The Deltoid Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint.
Ascension Orthopedics, Inc.
RET-920-20
In Commercial Distribution

  • M269RET920201 ()
  • 10381780246848 ()

  • 10.9 in L x 2.8 in W
RET-920-20

  • Hand-held surgical retractor, reusable

Integra® - 10381780246794

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
RET90001
In Commercial Distribution

  • M269RET900011 ()
  • 10381780246794 ()

  • 8.86 in L x 4.5 in W
RET-900-01

  • Hand-held surgical retractor, reusable

Integra® - 10381780246565

Integra® Total Foot System The Plate Bending Iron is used to bend pre-countored plates to match specific patient anatomy.
Ascension Orthopedics, Inc.
PBI80000
In Commercial Distribution

  • M269PBI800001 ()
  • 10381780246565 ()

  • 4.72 in L x .55 in W
PBI-800-00

  • Manual orthopaedic bender, reusable

First Choice® DRUJ System - 10381780246480

Integra® First Choice® DRUJ System MUH Resection Guide The Modular Ulnar Head Resection Guide is placed against the distal ulna to determine a standard, medium, or long resection of the ulnar head.
Ascension Orthopedics, Inc.
OSG60000
In Commercial Distribution

  • M269OSG600001 ()
  • 10381780246480 ()

  • 4.7 in L x 1.5 in W
OSG-600-00

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780244868

Surgical Instruments Trial Extractor
Ascension Orthopedics, Inc.
EXT20000
In Commercial Distribution

  • M269EXT200001 ()
  • 10381780244868 ()

  • 5.25 in L x 2.67 in W
EXT-200-00

  • Orthopaedic inorganic implant inserter/extractor, reusable

Construct ™ - 10381780244400

Construct® Ankle Fusion Plate System The double drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DDG-5010-01
Not in Commercial Distribution

  • M269DDG5010011 ()
  • 10381780244400 ()

  • 5.92 in L x 2.16 in W
DDG501001

  • Surgical drill guide, reusable

CAPTURE™ - 10381780243687

CAPTURE™ High Torque Screw System The Capture 7.0mm Instrument Drop Plate is a separate tray within the base where devices are held.
Ascension Orthopedics, Inc.
CSA-5000-006
In Commercial Distribution

  • M269CSA50000061 ()
  • 10381780243687 ()

  • 12.47 in L x 7.35 in W
CSA5000006

  • Instrument tray, reusable
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