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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 - 00889795114235

Grappler Suture Anchor, Titanium, ø4.5 x 15mm, Sterile Kit
Paragon 28, Inc.
P44-110-4515-SK
In Commercial Distribution

  • 00889795114235 ()
P44-110-4515-SK

  • General internal orthopaedic fixation system implantation kit

Grappler™ Suture Anchor System - 00889795114228

Grappler Suture Anchor, Titanium, ø3.0 x 10mm, Sterile Kit
Paragon 28, Inc.
P44-110-3010-SK
In Commercial Distribution

  • 00889795114228 ()
P44-110-3010-SK

  • General internal orthopaedic fixation system implantation kit

Bun-Yo-Matic™ Lapidus Clamp System - 00889795114129

K-wire Tube, 150mm MAX
Paragon 28, Inc.
P31-941-0150
In Commercial Distribution

  • 00889795114129 ()
P31-941-0150

  • Device sterilization/disinfection container, reusable

JAWS Staple System - 00889795114082

JAWS Staple, 12mm, 12 x 12 Straight
Paragon 28, Inc.
P71-012-1212-S
In Commercial Distribution

  • 00889795114082 ()
P71-012-1212-S

  • Orthopaedic bone staple, non-adjustable

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

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

APEX 3D Total Ankle Replacement System - 00889795100290

DECOUPLED TALAR RESECTION, +7MM (F), DUAL SHIM
Paragon 28, Inc.
P10-942-DT07
In Commercial Distribution

  • 00889795100290 ()
P10-942-DT07

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100283

DECOUPLED TALAR RESECTION, +6MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT06
In Commercial Distribution

  • 00889795100283 ()
P10-942-DT06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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