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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 - 00889795111128

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 4
Paragon 28, Inc.
P10-944-PSI4
In Commercial Distribution

  • 00889795111128 ()
P10-944-PSI4

  • Osteotomy guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110893

Ø2.7 Gorilla Tap
Paragon 28, Inc.
P51-911-2700
In Commercial Distribution

  • 00889795110893 ()
P51-911-2700

  • Bone tap, reusable

APEX 3D Total Ankle Replacement System - 00889795110886

Saw Blade 8 x 90mm, 1.27mm, Stryker
Paragon 28, Inc.
P99-151-P106-S
In Commercial Distribution

  • 00889795110886 ()
P99-151-P106-S

  • Surgical saw blade, sagittal, single-use

APEX 3D Total Ankle Replacement System - 00889795110862

Saw Blade 13 x 90mm, 1.27mm, Stryker
Paragon 28, Inc.
P99-151-P104-S
In Commercial Distribution

  • 00889795110862 ()
P99-151-P104-S

  • Surgical saw blade, sagittal, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795110824

Proximal Arm Assembly
Paragon 28, Inc.
P31-950-0035
In Commercial Distribution

  • 00889795110824 ()
P31-950-0035

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110817

R3CON Non-Locking Screw, Ø3.50 x 100mm
Paragon 28, Inc.
P50-453-3500
In Commercial Distribution

  • 00889795110817 ()
P50-453-3500

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

APEX 3D Total Ankle Replacement System - 00889795110695

TOTAL ANKLE, INSTRUMENT, CHAMFER CHECKER, AP DOUBLE-ENDED, V2.0
Paragon 28, Inc.
P10-944-TCC4
In Commercial Distribution

  • 00889795110695 ()
P10-944-TCC4

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110688

TOTAL ANKLE, INSTRUMENT, CHAMFER CHECKER, ALL-IN-ONE, V2.0
Paragon 28, Inc.
P10-944-TCC3
In Commercial Distribution

  • 00889795110688 ()
P10-944-TCC3

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110671

Total Ankle Replacement System, Poly Trial Insert, Size 5, 20mm
Paragon 28, Inc.
P10-930-I520
In Commercial Distribution

  • 00889795110671 ()
P10-930-I520

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110664

Total Ankle Replacement System, Poly Trial Insert, Size 5, 18mm
Paragon 28, Inc.
P10-930-I518
In Commercial Distribution

  • 00889795110664 ()
P10-930-I518

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110657

Total Ankle Replacement System, Poly Trial Insert, Size 5, 16mm
Paragon 28, Inc.
P10-930-I516
In Commercial Distribution

  • 00889795110657 ()
P10-930-I516

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110640

Total Ankle Replacement System, Poly Trial Insert, Size 5, 14mm
Paragon 28, Inc.
P10-930-I514
In Commercial Distribution

  • 00889795110640 ()
P10-930-I514

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110633

Total Ankle Replacement System, Poly Trial Insert, Size 4, 20mm
Paragon 28, Inc.
P10-930-I420
In Commercial Distribution

  • 00889795110633 ()
P10-930-I420

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110626

Total Ankle Replacement System, Poly Trial Insert, Size 4, 18mm
Paragon 28, Inc.
P10-930-I418
In Commercial Distribution

  • 00889795110626 ()
P10-930-I418

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110619

Total Ankle Replacement System, Poly Trial Insert, Size 4, 16mm
Paragon 28, Inc.
P10-930-I416
In Commercial Distribution

  • 00889795110619 ()
P10-930-I416

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110602

Total Ankle Replacement System, Poly Trial Insert, Size 4, 14mm
Paragon 28, Inc.
P10-930-I414
In Commercial Distribution

  • 00889795110602 ()
P10-930-I414

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110596

Total Ankle Replacement System, Poly Trial Insert, Size 3, 20mm
Paragon 28, Inc.
P10-930-I320
In Commercial Distribution

  • 00889795110596 ()
P10-930-I320

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110589

Total Ankle Replacement System, Poly Trial Insert, Size 3, 18mm
Paragon 28, Inc.
P10-930-I318
In Commercial Distribution

  • 00889795110589 ()
P10-930-I318

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110572

Total Ankle Replacement System, Poly Trial Insert, Size 3, 16mm
Paragon 28, Inc.
P10-930-I316
In Commercial Distribution

  • 00889795110572 ()
P10-930-I316

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110565

Total Ankle Replacement System, Poly Trial Insert, Size 3, 14mm
Paragon 28, Inc.
P10-930-I314
In Commercial Distribution

  • 00889795110565 ()
P10-930-I314

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110558

Total Ankle Replacement System, Poly Trial Insert, Size 2, 20mm
Paragon 28, Inc.
P10-930-I220
In Commercial Distribution

  • 00889795110558 ()
P10-930-I220

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110541

Total Ankle Replacement System, Poly Trial Insert, Size 2, 18mm
Paragon 28, Inc.
P10-930-I218
In Commercial Distribution

  • 00889795110541 ()
P10-930-I218

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110534

Total Ankle Replacement System, Poly Trial Insert, Size 2, 16mm
Paragon 28, Inc.
P10-930-I216
In Commercial Distribution

  • 00889795110534 ()
P10-930-I216

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110527

Total Ankle Replacement System, Poly Trial Insert, Size 2, 14mm
Paragon 28, Inc.
P10-930-I214
In Commercial Distribution

  • 00889795110527 ()
P10-930-I214

  • Surgical implant template, reusable

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 - 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

Baby Gorilla®/Gorilla® Plating System - 00889795110251

Silverback Gorilla Lateral TTC Plate Template, Standard, Left
Paragon 28, Inc.
P54-402-L101
In Commercial Distribution

  • 00889795110251 ()
P54-402-L101

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

Baby Gorilla®/Gorilla® Plating System - 00889795110121

Silverback Gorilla Anterior TT Plate Template, Standard, Contoured, Left
Paragon 28, Inc.
P54-401-L101
In Commercial Distribution

  • 00889795110121 ()
P54-401-L101

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

Paratrooper™ Plantar Plate Repair System - 00889795107596

Paratrooper Caddy Lid
Paragon 28, Inc.
P13-900-ALID
In Commercial Distribution

  • 00889795107596 ()
P13-900-ALID

  • Device sterilization/disinfection container, reusable

Grappler Interference Screw System - 00889795107572

Blind Tunnel Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P41-980-1000
In Commercial Distribution

  • 00889795107572 ()
P41-980-1000

  • Suturing unit, single-use

Grappler Interference Screw System - 00889795107558

Ø7.0/8.0 Driver Sleeve
Paragon 28, Inc.
P41-942-7080
In Commercial Distribution

  • 00889795107558 ()
P41-942-7080

  • Orthopaedic implantation sleeve, reusable

Grappler Interference Screw System - 00889795107541

Ø5.5/6.0 Driver Sleeve
Paragon 28, Inc.
P41-942-5560
In Commercial Distribution

  • 00889795107541 ()
P41-942-5560

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795100436

R3CON Non-Locking Screw, Ø3.50 x 54mm
Paragon 28, Inc.
P50-453-3554
In Commercial Distribution

  • 00889795100436 ()
P50-453-3554

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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