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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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Phantom Hindfoot TTC/TC Nail System - 00889795130891

3/16th Adapter
Paragon 28, Inc.
P99-000-316B
In Commercial Distribution

  • 00889795130891 ()
P99-000-316B

  • Surgical screwdriver, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129420

5mm Female Hex Driver
Paragon 28, Inc.
P99-150-FHX5
In Commercial Distribution

  • 00889795129420 ()
P99-150-FHX5

  • Surgical screwdriver, reusable

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

APEX 3D S Total Ankle Replacement System - 00889795136824

Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use

APEX 3D Total Ankle Replacement System - 00889795136800

3.5 Hex Driver, Ball Nose, Short
Paragon 28, Inc.
P99-150-HB35-SHORT
In Commercial Distribution

  • 00889795136800 ()
P99-150-HB35-SHORT

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795135001

Small Mallet
Paragon 28, Inc.
P36-970-0002
In Commercial Distribution

  • 00889795135001 ()
P36-970-0002

  • Surgical mallet

Phantom® Fibula Nail System - 00889795134981

T25 Hexalobe Driver, AO Quick Connect
Paragon 28, Inc.
P36-940-TT25
In Commercial Distribution

  • 00889795134981 ()
P36-940-TT25

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795134974

T10 Hexalobe Driver, Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-940-TT10
In Commercial Distribution

  • 00889795134974 ()
P36-940-TT10

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795133854

Actuation Driver, 2.0mm Hex, Sterile
Paragon 28, Inc.
P36-940-0001-S
Not in Commercial Distribution

  • 00889795133854 ()
P36-940-0001-S

  • Surgical screwdriver, single-use
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