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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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Baby Gorilla®/Gorilla® Plating System - 00889795112378

Posterior Span Plate, Flat, Long, Right, 09-Hole, TiA
Paragon 28, Inc.
P53-423-R202
In Commercial Distribution

  • 00889795112378 ()
P53-423-R202

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

Baby Gorilla®/Gorilla® Plating System - 00889795112361

Posterior Span Plate, Flat, Long, Left, 09-Hole, TiA
Paragon 28, Inc.
P53-423-L202
In Commercial Distribution

  • 00889795112361 ()
P53-423-L202

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

Baby Gorilla®/Gorilla® Plating System - 00889795112354

Posterior Span Plate, Flat, Standard, Right, 09-Hole, TiA
Paragon 28, Inc.
P53-423-R201
In Commercial Distribution

  • 00889795112354 ()
P53-423-R201

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

Baby Gorilla®/Gorilla® Plating System - 00889795112347

Posterior Span Plate, Flat, Standard, Left, 09-Hole, TiA
Paragon 28, Inc.
P53-423-L201
In Commercial Distribution

  • 00889795112347 ()
P53-423-L201

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

Baby Gorilla®/Gorilla® Plating System - 00889795112330

Lateral Span Plate, Flat, Long, Right, 15-Hole, TiA
Paragon 28, Inc.
P53-422-R202
In Commercial Distribution

  • 00889795112330 ()
P53-422-R202

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

Baby Gorilla®/Gorilla® Plating System - 00889795112323

Lateral Span Plate, Flat, Long, Left, 15-Hole, TiA
Paragon 28, Inc.
P53-422-L202
In Commercial Distribution

  • 00889795112323 ()
P53-422-L202

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

Baby Gorilla®/Gorilla® Plating System - 00889795112316

Lateral Span Plate, Flat, Standard, Right, 15-Hole, TiA
Paragon 28, Inc.
P53-422-R201
In Commercial Distribution

  • 00889795112316 ()
P53-422-R201

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

Baby Gorilla®/Gorilla® Plating System - 00889795111821

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 24mm
Paragon 28, Inc.
P50-853-3524
In Commercial Distribution

  • 00889795111821 ()
P50-853-3524

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

Baby Gorilla®/Gorilla® Plating System - 00889795111814

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 22mm
Paragon 28, Inc.
P50-853-3522
In Commercial Distribution

  • 00889795111814 ()
P50-853-3522

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

Baby Gorilla®/Gorilla® Plating System - 00889795111807

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 20mm
Paragon 28, Inc.
P50-853-3520
In Commercial Distribution

  • 00889795111807 ()
P50-853-3520

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

Baby Gorilla®/Gorilla® Plating System - 00889795111791

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 40mm
Paragon 28, Inc.
P50-753-3540
In Commercial Distribution

  • 00889795111791 ()
P50-753-3540

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

Baby Gorilla®/Gorilla® Plating System - 00889795111784

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 38mm
Paragon 28, Inc.
P50-753-3538
In Commercial Distribution

  • 00889795111784 ()
P50-753-3538

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

Baby Gorilla®/Gorilla® Plating System - 00889795111777

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 36mm
Paragon 28, Inc.
P50-753-3536
In Commercial Distribution

  • 00889795111777 ()
P50-753-3536

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

Baby Gorilla®/Gorilla® Plating System - 00889795111760

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 34mm
Paragon 28, Inc.
P50-753-3534
In Commercial Distribution

  • 00889795111760 ()
P50-753-3534

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

Baby Gorilla®/Gorilla® Plating System - 00889795111753

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 32mm
Paragon 28, Inc.
P50-753-3532
In Commercial Distribution

  • 00889795111753 ()
P50-753-3532

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

Baby Gorilla®/Gorilla® Plating System - 00889795111746

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 30mm
Paragon 28, Inc.
P50-753-3530
In Commercial Distribution

  • 00889795111746 ()
P50-753-3530

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

Baby Gorilla®/Gorilla® Plating System - 00889795111739

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 28mm
Paragon 28, Inc.
P50-753-3528
In Commercial Distribution

  • 00889795111739 ()
P50-753-3528

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

Baby Gorilla®/Gorilla® Plating System - 00889795111722

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 26mm
Paragon 28, Inc.
P50-753-3526
In Commercial Distribution

  • 00889795111722 ()
P50-753-3526

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

Baby Gorilla®/Gorilla® Plating System - 00889795111715

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 24mm
Paragon 28, Inc.
P50-753-3524
In Commercial Distribution

  • 00889795111715 ()
P50-753-3524

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

Baby Gorilla®/Gorilla® Plating System - 00889795111708

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 22mm
Paragon 28, Inc.
P50-753-3522
In Commercial Distribution

  • 00889795111708 ()
P50-753-3522

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

Baby Gorilla®/Gorilla® Plating System - 00889795111692

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 20mm
Paragon 28, Inc.
P50-753-3520
In Commercial Distribution

  • 00889795111692 ()
P50-753-3520

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

Baby Gorilla®/Gorilla® Plating System - 00889795111685

MINI HOHMANN RETRACTOR 15mm blade 16cm, SS
Paragon 28, Inc.
P99-150-0052
In Commercial Distribution

  • 00889795111685 ()
P99-150-0052

  • Hand-held surgical retractor, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111678

MINI HOHMANN RETRACTOR 16cm, SS
Paragon 28, Inc.
P99-150-0051
In Commercial Distribution

  • 00889795111678 ()
P99-150-0051

  • Hand-held surgical retractor, reusable

APEX 3D Total Ankle Replacement System - 00889795111609

MAVEN, TOTAL ANKLE, PSI, TIBIA TRIAL SPACER, RIGHT
Paragon 28, Inc.
P10-PSI-R105
In Commercial Distribution

  • 00889795111609 ()
P10-PSI-R105

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111593

MAVEN, TOTAL ANKLE, PSI, TIBIA TRIAL SPACER, LEFT
Paragon 28, Inc.
P10-PSI-L105
In Commercial Distribution

  • 00889795111593 ()
P10-PSI-L105

  • Surgical implant template, single-use

APEX 3D Total Ankle Replacement System - 00889795111586

MAVEN, TOTAL ANKLE, PSI, TALUS GUIDE, RIGHT
Paragon 28, Inc.
P10-PSI-R104
In Commercial Distribution

  • 00889795111586 ()
P10-PSI-R104

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111579

MAVEN, TOTAL ANKLE, PSI, TALUS GUIDE, LEFT
Paragon 28, Inc.
P10-PSI-L104
In Commercial Distribution

  • 00889795111579 ()
P10-PSI-L104

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111562

MAVEN, TOTAL ANKLE, PSI, TIBIA GUIDE, RIGHT
Paragon 28, Inc.
P10-PSI-R103
In Commercial Distribution

  • 00889795111562 ()
P10-PSI-R103

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111555

MAVEN, TOTAL ANKLE, PSI, TIBIA GUIDE, LEFT
Paragon 28, Inc.
P10-PSI-L103
In Commercial Distribution

  • 00889795111555 ()
P10-PSI-L103

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111548

MAVEN, TOTAL ANKLE, PSI, TALUS BONE MODEL, RIGHT
Paragon 28, Inc.
P10-PSI-R102
In Commercial Distribution

  • 00889795111548 ()
P10-PSI-R102

  • Custom-made orthopaedic/craniofacial surgical guide

APEX 3D Total Ankle Replacement System - 00889795111531

MAVEN, TOTAL ANKLE, PSI, TALUS BONE MODEL, LEFT
Paragon 28, Inc.
P10-PSI-L102
In Commercial Distribution

  • 00889795111531 ()
P10-PSI-L102

  • Custom-made orthopaedic/craniofacial surgical guide

APEX 3D Total Ankle Replacement System - 00889795111524

MAVEN, TOTAL ANKLE, PSI, TIBIA BONE MODEL, RIGHT
Paragon 28, Inc.
P10-PSI-R101
In Commercial Distribution

  • 00889795111524 ()
P10-PSI-R101

  • Custom-made orthopaedic/craniofacial surgical guide

APEX 3D Total Ankle Replacement System - 00889795111517

MAVEN, TOTAL ANKLE, PSI, TIBIA BONE MODEL, LEFT
Paragon 28, Inc.
P10-PSI-L101
In Commercial Distribution

  • 00889795111517 ()
P10-PSI-L101

  • Custom-made orthopaedic/craniofacial surgical guide

R3ACT Stabilization System - 00889795111388

R3ACT Caddy Lid
Paragon 28, Inc.
P80-900-0004-2
In Commercial Distribution

  • 00889795111388 ()
P80-900-0004-2

  • Device sterilization/disinfection container, reusable

R3ACT Stabilization System - 00889795111371

R3ACT Caddy
Paragon 28, Inc.
P80-900-0004-1
In Commercial Distribution

  • 00889795111371 ()
P80-900-0004-1

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795111340

Curette, 9mm, 45 Degrees
Paragon 28, Inc.
P99-150-0098
In Commercial Distribution

  • 00889795111340 ()
P99-150-0098

  • Bone curette, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111326

Ankle Fracture, Hook Plate Inserter
Paragon 28, Inc.
P51-922-1006
In Commercial Distribution

  • 00889795111326 ()
P51-922-1006

  • Orthopaedic implant aiming/guiding block attachment tool

Baby Gorilla®/Gorilla® Plating System - 00889795111319

Periosteal Elevator
Paragon 28, Inc.
P99-150-2004
In Commercial Distribution

  • 00889795111319 ()
P99-150-2004

  • Periosteal elevator, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111302

Langenbeck Elevator
Paragon 28, Inc.
P99-150-2003
In Commercial Distribution

  • 00889795111302 ()
P99-150-2003

  • Periosteal elevator, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111296

Fracture Reduction Clamp (Pig Sticker)
Paragon 28, Inc.
P99-150-0134
In Commercial Distribution

  • 00889795111296 ()
P99-150-0134

  • Bone approximation clamp

Baby Gorilla®/Gorilla® Plating System - 00889795111289

Gorilla, Ankle Fracture, Hook Plate Template, Lateral Mal.
Paragon 28, Inc.
P51-922-1005
In Commercial Distribution

  • 00889795111289 ()
P51-922-1005

  • Surgical implant template, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111272

Gorilla, Tap, Cortical Ø3.5mm
Paragon 28, Inc.
P51-911-3501
In Commercial Distribution

  • 00889795111272 ()
P51-911-3501

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111265

R3CON, Ø4.2mm Drill sleeve
Paragon 28, Inc.
P51-905-2842-03
In Commercial Distribution

  • 00889795111265 ()
P51-905-2842-03

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111258

Gorilla R3CON, Drill / Over Drill Guide, Double Ended 2.8 / 4.2 ,SS
Paragon 28, Inc.
P51-905-2842
In Commercial Distribution

  • 00889795111258 ()
P51-905-2842

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111241

R3CON, Ø3.5mm Drill sleeve
Paragon 28, Inc.
P51-905-2435-03
In Commercial Distribution

  • 00889795111241 ()
P51-905-2435-03

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111234

Gorilla R3CON, Drill / Over Drill Guide, Double Ended 2.4 / 3.5 ,SS
Paragon 28, Inc.
P51-905-2435
In Commercial Distribution

  • 00889795111234 ()
P51-905-2435

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111227

R3CON, Ø2.7mm Drill sleeve
Paragon 28, Inc.
P51-905-2027-03
In Commercial Distribution

  • 00889795111227 ()
P51-905-2027-03

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111210

Gorilla R3CON, Drill / Over Drill Guide, Double Ended 2.0 / 2.7 ,SS
Paragon 28, Inc.
P51-905-2027
In Commercial Distribution

  • 00889795111210 ()
P51-905-2027

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111203

Gorilla R3CON, Drill Guide, Centering, 3.5mm Cortical, SS, Long
Paragon 28, Inc.
P51-902-1008
In Commercial Distribution

  • 00889795111203 ()
P51-902-1008

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111197

Drill guide, EZ Cone Ø4.2mm, Long
Paragon 28, Inc.
P51-901-5042
In Commercial Distribution

  • 00889795111197 ()
P51-901-5042

  • Surgical drill guide, reusable
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