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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, 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, 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, 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 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, Small, Titanium
Paragon 28, Inc.
AOPSTSXXXXS-TI
In Commercial Distribution

  • 00889795128133 ()
AOPSTSXXXXS-TI

  • Coated ankle talus prosthesis
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, Large, Titanium
Paragon 28, Inc.
AOPSTSXXXXL-TI
In Commercial Distribution

  • 00889795128119 ()
AOPSTSXXXXL-TI

  • Coated ankle talus prosthesis
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 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 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 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 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 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
1/3 Tubular Plate, 2 Hole
Paragon 28, Inc.
P53-201-1002
In Commercial Distribution

  • 00889795127945 ()
P53-201-1002

  • Orthopaedic fixation plate, non-bioabsorbable
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
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
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
Half Pin, Self Drilling, Ø5.0 X 30mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-5030-S
In Commercial Distribution

  • 00889795126771 ()
P45-199-5030-S

  • External orthopaedic fixation system, single-use
Gorilla, SMO, Case Base
Paragon 28, Inc.
P50-900-SMCB
In Commercial Distribution

  • 00889795124586 ()
P50-900-SMCB

  • Device sterilization/disinfection container, reusable
Total Ankle, Instrument, Fluted Single Peg Punch, Right
Paragon 28, Inc.
P10-851-R001
In Commercial Distribution

  • 00889795124579 ()
P10-851-R001

  • Bone-coring punch, reusable
Total Ankle, Instrument, Fluted Single Peg Punch, Left
Paragon 28, Inc.
P10-851-L001
In Commercial Distribution

  • 00889795124562 ()
P10-851-L001

  • Bone-coring punch, reusable
Bevel Nut, 10mm
Paragon 28, Inc.
P45-940-1001
In Commercial Distribution

  • 00889795124555 ()
P45-940-1001

  • External orthopaedic fixation system, single-use
Corner Osteotome
Paragon 28, Inc.
P10-901-CC01
In Commercial Distribution

  • 00889795124548 ()
P10-901-CC01

  • Orthopaedic osteotome
SMO, Medial Cut Guide
Paragon 28, Inc.
P51-912-MLC1
In Commercial Distribution

  • 00889795124524 ()
P51-912-MLC1

  • Surgical drill guide, reusable
SMO, Medial Sextant Jig
Paragon 28, Inc.
P51-912-ML01
In Commercial Distribution

  • 00889795124517 ()
P51-912-ML01

  • Surgical drill guide, reusable
SMO, Angelwing
Paragon 28, Inc.
P51-912-AW01
In Commercial Distribution

  • 00889795124500 ()
P51-912-AW01

  • Surgical drill guide, reusable
SMO, Insert, R50
Paragon 28, Inc.
P51-912-AND8
In Commercial Distribution

  • 00889795124494 ()
P51-912-AND8

  • Surgical drill guide, reusable
SMO, Insert, R45
Paragon 28, Inc.
P51-912-AND7
In Commercial Distribution

  • 00889795124487 ()
P51-912-AND7

  • Surgical drill guide, reusable
SMO, Insert, R40
Paragon 28, Inc.
P51-912-AND6
In Commercial Distribution

  • 00889795124470 ()
P51-912-AND6

  • Surgical drill guide, reusable
SMO, Insert, R35
Paragon 28, Inc.
P51-912-AND5
In Commercial Distribution

  • 00889795124463 ()
P51-912-AND5

  • Surgical drill guide, reusable
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