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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 - 10381780365372

Insert, Size 01, Left, TH13
Ascension Orthopedics, Inc.
LJV314T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365365

Insert, Size 01, Left, TH11
Ascension Orthopedics, Inc.
LJV313T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365358

Insert, Size 01, Left, TH10
Ascension Orthopedics, Inc.
LJV312T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365341

Insert, Size 01, Left, TH9
Ascension Orthopedics, Inc.
LJV311T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365334

Insert, Size 01, Left, TH8
Ascension Orthopedics, Inc.
LJV310T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365327

Insert, Size 00, Right, TH21
Ascension Orthopedics, Inc.
LJU416T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365310

Insert, Size 00, Right, TH19
Ascension Orthopedics, Inc.
LJU415T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365303

Insert, Size 00, Right, TH17
Ascension Orthopedics, Inc.
LJU414T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365297

Insert, Size 00, Right, TH15
Ascension Orthopedics, Inc.
LJU413T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365280

Insert, Size 00, Right, TH13
Ascension Orthopedics, Inc.
LJU412T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis
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