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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 - 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

Baby Gorilla®/Gorilla® Plating System - 00889795111180

Drill Guide, EZ Cone Ø3.5mm, Long
Paragon 28, Inc.
P51-901-5035
In Commercial Distribution

  • 00889795111180 ()
P51-901-5035

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111173

Drill Guide, EZ Cone Ø2.7mm, Long
Paragon 28, Inc.
P51-901-5027
In Commercial Distribution

  • 00889795111173 ()
P51-901-5027

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111166

Kocher Clamp, Straight, 1x2 Teeth, 160mm
Paragon 28, Inc.
P99-150-KC01
In Commercial Distribution

  • 00889795111166 ()
P99-150-KC01

  • Bone approximation clamp

APEX 3D Total Ankle Replacement System - 00889795111159

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 5
Paragon 28, Inc.
P10-944-PSI5
In Commercial Distribution

  • 00889795111159 ()
P10-944-PSI5

  • Osteotomy guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111142

Gorilla, R3con, Drill Guide Compression Slot, 4.2 Long
Paragon 28, Inc.
P51-903-3006
In Commercial Distribution

  • 00889795111142 ()
P51-903-3006

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111135

Gorilla, R3con, Drill Guide Compression Slot, 3.5 Long
Paragon 28, Inc.
P51-903-3005
In Commercial Distribution

  • 00889795111135 ()
P51-903-3005

  • Surgical drill guide, reusable

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

APEX 3D Total Ankle Replacement System - 00889795111111

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow
Paragon 28, Inc.
P10-944-PSI0
In Commercial Distribution

  • 00889795111111 ()
P10-944-PSI0

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111104

Total Ankle, Revision Poly Caddy
Paragon 28, Inc.
P10-900-RVNP
In Commercial Distribution

  • 00889795111104 ()
P10-900-RVNP

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111098

Gorilla, R3con, Drill Guide Compression Slot, 2.7 Long
Paragon 28, Inc.
P51-903-3004
In Commercial Distribution

  • 00889795111098 ()
P51-903-3004

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111067

Laser Alignment Guide
Paragon 28, Inc.
P10-941-LAZM
In Commercial Distribution

  • 00889795111067 ()
P10-941-LAZM

  • Orthopaedic fixation implant alignment tool

Lesser Metatarsal Shortening System - 00889795111029

Saw Blade 9 x 31 x .051mm Stryker (Sterile)
Paragon 28, Inc.
P99-151-P30S-1-S
In Commercial Distribution

  • 00889795111029 ()
P99-151-P30S-1-S

  • Surgical saw blade, oscillating, single-use

Lesser Metatarsal Shortening System - 00889795111012

Saw Blade 9 x 31 x .051mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P30M-1-S
In Commercial Distribution

  • 00889795111012 ()
P99-151-P30M-1-S

  • Surgical saw blade, oscillating, single-use

MgNum - 00889795111005

MgNum, Bone Void Filler, Mixing and Delivery System
Paragon 28, Inc.
P02-BVF-AUX1
In Commercial Distribution

  • 00889795111005 ()
P02-BVF-AUX1

  • Bone graft delivery kit

MgNum - 00889795110992

MgNum, Bone Void Filler, 15cc
Paragon 28, Inc.
P02-BVF-0015
In Commercial Distribution

  • 00889795110992 ()
P02-BVF-0015

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110985

MgNum, Bone Void Filler, 10cc
Paragon 28, Inc.
P02-BVF-0010
In Commercial Distribution

  • 00889795110985 ()
P02-BVF-0010

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110978

MgNum, Bone Void Filler, 5cc
Paragon 28, Inc.
P02-BVF-0005
In Commercial Distribution

  • 00889795110978 ()
P02-BVF-0005

  • Bone matrix implant, synthetic, non-antimicrobial

APEX 3D Total Ankle Replacement System - 00889795110961

HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110954

Screw Retention Sleeve
Paragon 28, Inc.
P99-191-SL10
In Commercial Distribution

  • 00889795110954 ()
P99-191-SL10

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110947

Gorilla, Ankle Fx, Threaded Positioning Tower, LONG
Paragon 28, Inc.
P51-900-2002
In Commercial Distribution

  • 00889795110947 ()
P51-900-2002

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110930

Ø3.5 x 13cm Solid Over Drill
Paragon 28, Inc.
P99-100-3513
In Commercial Distribution

  • 00889795110930 ()
P99-100-3513

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110923

Ø2.0 x 14cm Solid Drill
Paragon 28, Inc.
P99-100-2013
In Commercial Distribution

  • 00889795110923 ()
P99-100-2013

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110916

Ø4.2 Gorilla Tap
Paragon 28, Inc.
P51-911-4200
In Commercial Distribution

  • 00889795110916 ()
P51-911-4200

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110909

Ø3.5 Gorilla Tap
Paragon 28, Inc.
P51-911-3500
In Commercial Distribution

  • 00889795110909 ()
P51-911-3500

  • Bone tap, 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
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