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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™ Suture Anchor System - 00889795123923

Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-5515-SK
In Commercial Distribution

  • 00889795123923 ()
P44-131-5515-SK

  • General internal orthopaedic fixation system implantation kit

Grappler™ Suture Anchor System - 00889795123916

Grappler Knotless Anchor, PEEK, ø4.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-4515-SK
In Commercial Distribution

  • 00889795123916 ()
P44-131-4515-SK

  • General internal orthopaedic fixation system implantation kit

Lesser Metatarsal Shortening System - 00889795123848

Saw Blade 5.5 x 25 x 0.4/0.6mm, Stryker (Sterile)
Paragon 28, Inc.
P99-151-P35S-S
In Commercial Distribution

  • 00889795123848 ()
P99-151-P35S-S

  • Surgical saw blade, oscillating, single-use

Lesser Metatarsal Shortening System - 00889795123831

Saw Blade 5.5 x 25 x 0.4/0.6mm, MicroAir (Sterile)
Paragon 28, Inc.
P99-151-P35M-S
In Commercial Distribution

  • 00889795123831 ()
P99-151-P35M-S

  • Surgical saw blade, oscillating, single-use

APEX 3D Total Ankle Replacement System - 00889795120021

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 20MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I520-S
In Commercial Distribution

  • 00889795120021 ()
P10-31P-I520-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795120014

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 19MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I519-S
In Commercial Distribution

  • 00889795120014 ()
P10-31P-I519-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795120007

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 18MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I518-S
In Commercial Distribution

  • 00889795120007 ()
P10-31P-I518-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795119995

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 17MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I517-S
In Commercial Distribution

  • 00889795119995 ()
P10-31P-I517-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795119988

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 16MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I516-S
In Commercial Distribution

  • 00889795119988 ()
P10-31P-I516-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795119971

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 15MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I515-S
In Commercial Distribution

  • 00889795119971 ()
P10-31P-I515-S

  • Fixed-bearing total ankle prosthesis
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