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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 - 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

Salto Talaris® - 10381780365273

Insert, Size 00, Right, TH11
Ascension Orthopedics, Inc.
LJU411T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365266

Insert, Size 00, Right, TH10
Ascension Orthopedics, Inc.
LJU410T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365259

Insert, Size 00, Right, TH9
Ascension Orthopedics, Inc.
LJU409T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780365242

Insert, Size 00, Right, TH8
Ascension Orthopedics, Inc.
LJU408T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780365235

Insert, Size 00, Left, TH21
Ascension Orthopedics, Inc.
LJU426T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis
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