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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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APEX 3D Total Ankle Replacement System - 00889795110510

Total Ankle Replacement System, Poly Trial Insert, Size 1, 20mm
Paragon 28, Inc.
P10-930-I120
In Commercial Distribution

  • 00889795110510 ()
P10-930-I120

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110503

Total Ankle Replacement System, Poly Trial Insert, Size 1, 18mm
Paragon 28, Inc.
P10-930-I118
In Commercial Distribution

  • 00889795110503 ()
P10-930-I118

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110497

Total Ankle Replacement System, Poly Trial Insert, Size 1, 16mm
Paragon 28, Inc.
P10-930-I116
In Commercial Distribution

  • 00889795110497 ()
P10-930-I116

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110480

Total Ankle Replacement System, Poly Trial Insert, Size 1, 14mm
Paragon 28, Inc.
P10-930-I114
In Commercial Distribution

  • 00889795110480 ()
P10-930-I114

  • Surgical implant template, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110442

Silverback Gorilla, Caddy Base, Posterior Plates
Paragon 28, Inc.
P50-900-SBPOS
In Commercial Distribution

  • 00889795110442 ()
P50-900-SBPOS

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110435

Precision Guide, Subtalar Joint, Guide Arm
Paragon 28, Inc.
P51-982-5101
In Commercial Distribution

  • 00889795110435 ()
P51-982-5101

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795110428

Precision Guide, Tibiotalar Joint, Guide Arm
Paragon 28, Inc.
P51-982-5001
In Commercial Distribution

  • 00889795110428 ()
P51-982-5001

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795110411

Posterior TTC Plate, Long, Flat, Right, 10-Hole, TiA
Paragon 28, Inc.
P53-403-R212
In Commercial Distribution

  • 00889795110411 ()
P53-403-R212

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110404

Posterior TTC Plate, Standard, Flat, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R211
In Commercial Distribution

  • 00889795110404 ()
P53-403-R211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110398

Posterior TTC Plate, Long, Flat, Left, 10-Hole, TiA
Paragon 28, Inc.
P53-403-L212
In Commercial Distribution

  • 00889795110398 ()
P53-403-L212

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110381

Posterior TTC Plate, Standard, Flat, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L211
In Commercial Distribution

  • 00889795110381 ()
P53-403-L211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110374

Posterior TTC Plate, Long, Contoured, Right, 10-Hole, TiA
Paragon 28, Inc.
P53-403-R112
In Commercial Distribution

  • 00889795110374 ()
P53-403-R112

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110367

Posterior TTC Plate, Standard, Contoured, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R111
In Commercial Distribution

  • 00889795110367 ()
P53-403-R111

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110350

Posterior TTC Plate, Long, Contoured, Left, 10-Hole, TiA
Paragon 28, Inc.
P53-403-L112
In Commercial Distribution

  • 00889795110350 ()
P53-403-L112

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110343

Posterior TTC Plate, Standard, Contoured, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L111
In Commercial Distribution

  • 00889795110343 ()
P53-403-L111

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110336

Posterior TT Plate, Long, Flat, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R202
In Commercial Distribution

  • 00889795110336 ()
P53-403-R202

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110329

Posterior TT Plate, Standard, Flat, Right, 06-Hole, TiA
Paragon 28, Inc.
P53-403-R201
In Commercial Distribution

  • 00889795110329 ()
P53-403-R201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110312

Posterior TT Plate, Long, Flat, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L202
In Commercial Distribution

  • 00889795110312 ()
P53-403-L202

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110305

Posterior TT Plate, Standard, Flat, Left, 06-Hole, TiA
Paragon 28, Inc.
P53-403-L201
In Commercial Distribution

  • 00889795110305 ()
P53-403-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795110282

Silverback Gorilla Lateral TTC Plate Template, Standard, Right
Paragon 28, Inc.
P54-402-R101
In Commercial Distribution

  • 00889795110282 ()
P54-402-R101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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