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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 - 10381780366225

Insert, Size 3, Right, TH21
Ascension Orthopedics, Inc.
LJU283T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780366218

Insert, Size 3, Right, TH19
Ascension Orthopedics, Inc.
LJU282T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366201

Insert, Size 3, Right, TH17
Ascension Orthopedics, Inc.
LJU281T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366195

Insert, Size 3, Right, TH15
Ascension Orthopedics, Inc.
LJU280T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366188

Insert, Size 3, Right, TH13
Ascension Orthopedics, Inc.
LJU279T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366171

Insert, Size 3, Right, TH11
Ascension Orthopedics, Inc.
LJU278T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366164

Insert, Size 3, Right, TH10
Ascension Orthopedics, Inc.
LJU277T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366157

Insert, Size 3, Right, TH9
Ascension Orthopedics, Inc.
LJU276T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Salto Talaris® - 10381780366140

Insert, Size 3, Right, TH8
Ascension Orthopedics, Inc.
LJU275T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis

Integra® XT - 10381780366133

Insert, Size 3, Left, TH21
Ascension Orthopedics, Inc.
LJU293T
In Commercial Distribution



  • Fixed-bearing total ankle prosthesis
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