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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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Grappler Interference Screw System - 00889795128249

Grappler Interference Screw System, Screw, Ø4.5 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-045-1500-S
In Commercial Distribution

  • 00889795128249 ()
P41-045-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable

Grappler Interference Screw System - 00889795128232

Grappler Interference Screw System, Screw, Ø4.5 mm x 10 mm, Sterile
Paragon 28, Inc.
P41-045-1000-S
In Commercial Distribution

  • 00889795128232 ()
P41-045-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable

Grappler Interference Screw System - 00889795128225

Grappler Interference Screw System, Screw, Ø4 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-040-2000-S
In Commercial Distribution

  • 00889795128225 ()
P41-040-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable

Grappler Interference Screw System - 00889795128218

Grappler Interference Screw System, Screw, Ø4 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-040-1500-S
In Commercial Distribution

  • 00889795128218 ()
P41-040-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable

Grappler Interference Screw System - 00889795128201

Grappler Interference Screw System, Screw, Ø4 mm x 10 mm, Sterile
Paragon 28, Inc.
P41-040-1000-S
In Commercial Distribution

  • 00889795128201 ()
P41-040-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable

Monkey Rings™ External Fixation System - 00889795128157

Monkey Rings, Case 3, Caddy 3, Fasteners
Paragon 28, Inc.
P45-903-CAD3
In Commercial Distribution

  • 00889795128157 ()
P45-903-CAD3

  • Device sterilization/disinfection container, reusable

Grappler R3FLEX Stabilization System - 00889795128140

Grappler R3FLEX Single Implant Kit
Paragon 28, Inc.
P82-001-1237-SK
In Commercial Distribution

  • 00889795128140 ()
P82-001-1237-SK

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Patient Specific Talus Spacer - 00889795128133

Patient Specific Talus Spacer, Small, Titanium
Paragon 28, Inc.
AOPSTSXXXXS-TI
In Commercial Distribution

  • 00889795128133 ()
AOPSTSXXXXS-TI

  • Coated ankle talus prosthesis

Patient Specific Talus Spacer - 00889795128126

Patient Specific Talus Spacer, Nominal, Titanium
Paragon 28, Inc.
AOPSTSXXXXN-TI
In Commercial Distribution

  • 00889795128126 ()
AOPSTSXXXXN-TI

  • Coated ankle talus prosthesis

Patient Specific Talus Spacer - 00889795128119

Patient Specific Talus Spacer, Large, Titanium
Paragon 28, Inc.
AOPSTSXXXXL-TI
In Commercial Distribution

  • 00889795128119 ()
AOPSTSXXXXL-TI

  • Coated ankle talus prosthesis

APEX 3D Total Ankle Replacement System - 00889795128058

Flat Talus Trial Handling Tool
Paragon 28, Inc.
P10-953-FTL0
In Commercial Distribution

  • 00889795128058 ()
P10-953-FTL0

  • Surgical instrument handle, non-torque-limiting

Grappler Suture Anchor System - 00889795128041

Grappler ExO, ø4.75mm x 20mm Dynamic Knotless Anchor, Sterile Kit
Paragon 28, Inc.
P82-240-4820-SK
In Commercial Distribution

  • 00889795128041 ()
P82-240-4820-SK

  • General internal orthopaedic fixation system implantation kit

Grappler Suture Anchor System - 00889795128034

Grappler ExO, ø2.8mm All-Suture Anchor, Sterile Kit
Paragon 28, Inc.
P82-211-0028-SK
In Commercial Distribution

  • 00889795128034 ()
P82-211-0028-SK

  • General internal orthopaedic fixation system implantation kit

Grappler Suture Anchor System - 00889795128027

Grappler ExO, ø4.5mm x 15mm Titanium Anchor, Sterile Kit
Paragon 28, Inc.
P82-111-4515-SK
In Commercial Distribution

  • 00889795128027 ()
P82-111-4515-SK

  • General internal orthopaedic fixation system implantation kit

Grappler Suture Anchor System - 00889795128010

Grappler ExO R3INFORCE, Screwless Head Locking Anchor, Sterile Kit
Paragon 28, Inc.
P82-230-3500-SK
In Commercial Distribution

  • 00889795128010 ()
P82-230-3500-SK

  • General internal orthopaedic fixation system implantation kit

Grappler Suture Anchor System - 00889795128003

Grappler ExO R3INFORCE, ø4.2mm x 12mm Locking Anchor, Sterile Kit
Paragon 28, Inc.
P82-220-4212-SK
In Commercial Distribution

  • 00889795128003 ()
P82-220-4212-SK

  • General internal orthopaedic fixation system implantation kit

Baby Gorilla®/Gorilla® Plating System - 00889795127945

1/3 Tubular Plate, 2 Hole
Paragon 28, Inc.
P53-201-1002
In Commercial Distribution

  • 00889795127945 ()
P53-201-1002

  • Orthopaedic fixation plate, non-bioabsorbable

Monkey Rings™ External Fixation System - 00889795126801

Half Pin, Self Drilling, Ø6.0 X 35mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-6035-S
In Commercial Distribution

  • 00889795126801 ()
P45-199-6035-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795126795

Half Pin, Self Drilling, Ø6.0 X 30mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-6030-S
In Commercial Distribution

  • 00889795126795 ()
P45-199-6030-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795126788

Half Pin, Self Drilling, Ø5.0 X 35mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-5035-S
In Commercial Distribution

  • 00889795126788 ()
P45-199-5035-S

  • External orthopaedic fixation system, single-use
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