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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® XT - 10381780365471

Insert, Size 01, Right, TH15
Ascension Orthopedics, Inc.
LJV305T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365464

Insert, Size 01, Right, TH13
Ascension Orthopedics, Inc.
LJV304T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365457

Insert, Size 01, Right, TH11
Ascension Orthopedics, Inc.
LJV303T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365440

Insert, Size 01, Right, TH10
Ascension Orthopedics, Inc.
LJV302T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365433

Insert, Size 01, Right, TH9
Ascension Orthopedics, Inc.
LJV301T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365426

Insert, Size 01, Right, TH8
Ascension Orthopedics, Inc.
LJV300T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365419

Insert, Size 01, Left, TH21
Ascension Orthopedics, Inc.
LJV318T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365402

Insert, Size 01, Left, TH19
Ascension Orthopedics, Inc.
LJV317T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365396

Insert, Size 01, Left, TH17
Ascension Orthopedics, Inc.
LJV316T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365389

Insert, Size 01, Left, TH15
Ascension Orthopedics, Inc.
LJV315T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis
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