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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 - 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

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

APEX 3D Total Ankle Replacement System - 00889795100276

DECOUPLED TALAR RESECTION, +5MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT05
In Commercial Distribution

  • 00889795100276 ()
P10-942-DT05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100269

DECOUPLED TALAR RESECTION, +4MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT04
In Commercial Distribution

  • 00889795100269 ()
P10-942-DT04

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100252

DECOUPLED TALAR RESECTION, +3MM (C), DUAL SHIM
Paragon 28, Inc.
P10-942-DT03
In Commercial Distribution

  • 00889795100252 ()
P10-942-DT03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100245

DECOUPLED TALAR RESECTION, +2MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT02
In Commercial Distribution

  • 00889795100245 ()
P10-942-DT02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100238

DECOUPLED TALAR RESECTION, +1MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT01
In Commercial Distribution

  • 00889795100238 ()
P10-942-DT01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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