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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The Concentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-4416C
In Commercial Distribution

  • M269TRL09230104416C1 ()
  • 10381780235590 ()

  • 1.7 in dia x .63 in H
TRL-0923-010-4416C

  • Humeral head prosthesis trial, reusable
The Eccentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-4216E
In Commercial Distribution

  • M269TRL09230104216E1 ()
  • 10381780235583 ()

  • 1.7 in dia x .63 in H
TRL-0923-010-4216E

  • Humeral head prosthesis trial, reusable
The Concentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-4216C
In Commercial Distribution

  • M269TRL09230104216C1 ()
  • 10381780235576 ()

  • 1.7 in dia x .63 in H
TRL-0923-010-4216C

  • Humeral head prosthesis trial, reusable
The Eccentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-4015E
In Commercial Distribution

  • M269TRL09230104015E1 ()
  • 10381780235569 ()

  • 1.6 in dia x .591 in H
TRL-0923-010-4015E

  • Humeral head prosthesis trial, reusable
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
The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance.
Ascension Orthopedics, Inc.
TIWEDGEINSTP
Not in Commercial Distribution

  • M268TIWEDGEINSTP1 ()
  • 10381780237471 ()

  • 10.69 in L x 9.91 in W


  • General external orthopaedic fixation system implantation kit, reusable
PyroCarbon PIP Total Joint PIP Distal Template
Ascension Orthopedics, Inc.
TMP20001
In Commercial Distribution

  • M269TMP200011 ()
  • 10381780237457 ()

  • 2.378 in L x 2.418 in W
TMP-200-01

  • Surgical implant template, reusable
The Movement Great Toe proximal phalanx implant sizer allows for clear visualization of the implant size.
Ascension Orthopedics, Inc.
PIS89000
In Commercial Distribution

  • M269PIS890001 ()
  • 10381780237150 ()

  • 3.907 in L x 3.865 in W


  • Surgical implant template, reusable
PCS Implant Extractor used to remove implants.
Ascension Orthopedics, Inc.
EXT43001
In Commercial Distribution

  • M269EXT430011 ()
  • 10381780237044 ()

  • 7.9 in L x 3.1 in W
EXT-430-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005621
In Commercial Distribution

  • M269TRL90056211 ()
  • 10381780237037 ()

  • 2.245 in dia x .825 in H
TRL-900-56/21

  • Humeral head prosthesis trial, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005221
In Commercial Distribution

  • M269TRL90052211 ()
  • 10381780237020 ()

  • 2.047 in dia x .825 in H
TRL-900-52/21

  • Humeral head prosthesis trial, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005218
In Commercial Distribution

  • M269TRL90052181 ()
  • 10381780237013 ()

  • 2.047 in dia x .707 in H
TRL-900-52/18

  • Humeral head prosthesis trial, reusable
The Lunate Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL71504T
In Commercial Distribution

  • M269TRL71504T1 ()
  • 10381780236825 ()

  • .7205 in L x .5433 in H
TRL-715-04T

  • Carpometacarpal interpositional spacer prosthesis trial
The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.
Ascension Orthopedics, Inc.
TRL600H190
In Commercial Distribution

  • M269TRL600H1901 ()
  • 10381780236733 ()

  • .748 in dia x .433 in H
TRL-600-H190

  • Surgical implant template, reusable
The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.
Ascension Orthopedics, Inc.
TRL600H160
In Commercial Distribution

  • M269TRL600H1601 ()
  • 10381780236719 ()

  • .630 in dia x .433 in H
TRL-600-H160

  • Surgical implant template, reusable
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™ 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™ 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™ 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® 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
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
CAPTURE™ Cannulated Screw System The TH cannulated relief drill is used to create a pilot hole for the screw.
Ascension Orthopedics, Inc.
AI-4030
In Commercial Distribution

  • M269AI40301 ()
  • 10381780241973 ()

  • 2.740 in L x .035 in dia
AI4030

  • Cannulated surgical drill bit, single-use
CAPTURE™ Cannulated Screw System The overdrill is used with the TC-series 3.0/4.0 mm screws.
Ascension Orthopedics, Inc.
AI-3050
In Commercial Distribution

  • M269AI30501 ()
  • 10381780241904 ()

  • 4.72 in L x .07 in dia
AI-3050

  • Cannulated surgical drill bit, single-use
Titan™ Total Shoulder System The Taper Adapter allows for preparation and retraction of the humerus for glenoid preparation.
Ascension Orthopedics, Inc.
AT0920065001
In Commercial Distribution

  • M269ADT09200650011 ()
  • 10381780241768 ()

  • .60 in L x .32 in dia
ADT-0920-065-001

  • Orthopaedic implant/instrument assembling device
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
ADP90003
In Commercial Distribution

  • M269ADP900031 ()
  • 10381780241751 ()

  • 3.0 in L x .456 in dia
ADP-900-03

  • Orthopaedic implant-instrument extension adaptor, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
ADP90002
In Commercial Distribution

  • M269ADP900021 ()
  • 10381780241744 ()

  • 3.0 in L x .406 in dia
ADP-900-02

  • Orthopaedic implant-instrument extension adaptor, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
ADP90001
In Commercial Distribution

  • M269ADP900011 ()
  • 10381780241737 ()

  • 3.0 in L x .356 in dia
ADP-900-01

  • Orthopaedic implant-instrument extension adaptor, reusable
Titan™ Total Shoulder System The stem adaptor is used to evaluate the best fit adaptor in the Titan Total Shoulder system.
Ascension Orthopedics, Inc.
AA0950040502
In Commercial Distribution

  • M269ADA09500405021 ()
  • 10381780241720 ()

  • 3.9 in L x .450 in dia
ADA-0950-040-502

  • Orthopaedic implant-instrument extension adaptor, reusable
Titan™ Total Shoulder System TRIAL ADAPTOR TSS The Trial Adaptor is used to evaluate the best fit adaptor in the Titan Modular Total Shoulder System.
Ascension Orthopedics, Inc.
AA0950040501
In Commercial Distribution

  • M269ADA09500405011 ()
  • 10381780241713 ()

  • 3.9 in L x .450 in dia
ADA-0950-040-501

  • Bone tap, reusable
Integra® Total Foot System Olive Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
2227711
Not in Commercial Distribution

  • M26922277111 ()
  • 10381780241522 ()

  • 3.937 in L x .0433 in dia
2227711

  • Orthopaedic guidewire, reusable
CAPTURE™ Cannulated Screw System The Scarf Bone Clamp is used to hold and/or compress bone cuts during screw insertion.
Ascension Orthopedics, Inc.
AI-1014
In Commercial Distribution

  • M269AI10141 ()
  • 10381780241409 ()

  • 6.43 in L x 2.8 in W
AI1014

  • Bone approximation clamp
The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
Ascension Orthopedics, Inc.
050112
In Commercial Distribution

  • M2480501121 ()
  • 10381780065531 ()

  • .472 in dia x .59 in L
050112

  • Subtalar implant, non-bioabsorbable
The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
Ascension Orthopedics, Inc.
050110
In Commercial Distribution

  • M2480501101 ()
  • 10381780065524 ()

  • .939 in dia x .59 in L
050110

  • Subtalar implant, non-bioabsorbable
The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
Ascension Orthopedics, Inc.
050109
In Commercial Distribution

  • M2480501091 ()
  • 10381780065517 ()

  • .355 in dia x .59 in L
050109

  • Subtalar implant, non-bioabsorbable
The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
Ascension Orthopedics, Inc.
050108
In Commercial Distribution

  • M2480501081 ()
  • 10381780065500 ()

  • .314 in dia x .59 in L
050108

  • Subtalar implant, non-bioabsorbable
The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
Ascension Orthopedics, Inc.
050106
In Commercial Distribution

  • M2480501061 ()
  • 10381780065494 ()

  • .236 in dia x .59 in L
050106

  • Subtalar implant, non-bioabsorbable
The Mini Integra Spider Limited Wrist Fusion stainless steel plate includes six-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
070006
In Commercial Distribution

  • M2480700061 ()
  • 10381780064756 ()

  • .549 in dia x .15 in L
070006

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Spider Limited Wrist Fusion stainless steel plate includes eight-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
070005
In Commercial Distribution

  • M2480700051 ()
  • 10381780064749 ()

  • .640 in dia x .150 in L
070005

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Mini Integra Spider Limited Wrist Fusion titanium plate includes six-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
060006
In Commercial Distribution

  • M2480600061 ()
  • 10381780064664 ()

  • .549 in dia x .15 in L
060006

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Spider Limited Wrist Fusion titanium plate includes eight-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
060005
In Commercial Distribution

  • M2480600051 ()
  • 10381780064657 ()

  • .64 in dia. x .15 in L
060005

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis.
INTEGRA LIFESCIENCES CORPORATION
WRISTFUSESET
Not in Commercial Distribution

  • M268WRISTFUSESET0 ()
  • 10381780064350 ()

  • 20.10 in L x 10.84 in W
WRISTFUSESET

  • Orthopaedic fixation plate, non-bioabsorbable
The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint, as well as corresponding instrumentation. The radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. It is manufactured from cast CoCr alloy. The carpal component is a titanium plate which is fixed into the carpal bones with a cemented central peg and two titanium screws. Instrumentation is provided to assist in the surgical implantation.
Ascension Orthopedics, Inc.
UNI2SET
Not in Commercial Distribution

  • M268UNI2SET0 ()
  • 10381780064336 ()

  • 21.5 in L x 10.3 in W
UNI2SET

  • Total wrist prosthesis
The Integra External Fixation System two-post bridge 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.
12225223
Not in Commercial Distribution

  • 10381780125679 ()

  • 1.116 in L x 1.107 in W
12225223

  • External orthopaedic fixation system, reusable
A rockerbottom is attached to the bottom of the external device so that the patient may stand on it if needed. It is manufactured from aluminum and silicone rubber.
Ascension Orthopedics, Inc.
12225400
In Commercial Distribution

  • 10381780125563 ()

  • 10.71 in L x 10.11 in W
12225400

  • External orthopaedic fixation system, reusable
The k-wire washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel.
Ascension Orthopedics, Inc.
12220025
In Commercial Distribution

  • 10381780124986 ()

  • .394 in dia x .039 in H
12220025

  • External orthopaedic fixation system, reusable
The Integra External Fixation System k-wires are manufactured from stainless steel and are secured to the bone segment. They are 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. The olive wire is designed to include an oval area on the wire for alignment to a washer.
Ascension Orthopedics, Inc.
12220024
In Commercial Distribution

  • 10381780124979 ()

  • 20.87 in L x .079 in dia
12220024

  • External orthopaedic fixation system, reusable
The Integra External Fixation System k-wires are manufactured from stainless steel and are secured to the bone segment. They are 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. The olive wire is designed to include an oval area on the wire for alignment to a washer.
Ascension Orthopedics, Inc.
12220023
In Commercial Distribution

  • 10381780124962 ()

  • 15.75 in L x .079 in dia
12220023

  • External orthopaedic fixation system, reusable
The Integra External Fixation System k-wires are manufactured from stainless steel and are secured to the bone segment. They are 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.
12220021
In Commercial Distribution

  • 10381780124955 ()

  • 15.75 in L x .079 in dia
12220021

  • External orthopaedic fixation system, reusable
The Stem Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95002516165
Not in Commercial Distribution

  • M269TRL0950025161651 ()
  • 10381780124337 ()

  • .631 in dia x 6.5 in L


  • Humeral stem prosthesis trial, reusable
The Stem Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95002516125
Not in Commercial Distribution

  • M269TRL0950025161251 ()
  • 10381780124320 ()

  • .631 in dia x 4.92 in L


  • Humeral stem prosthesis trial, reusable
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