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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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Healix - 00810005666893

Stylet for 4.0 - 5.5 Screws. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-603
In Commercial Distribution

  • 00810005666893 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005666886

Stylet for 6.0 - 8.5 Screws. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-604
In Commercial Distribution

  • 00810005666886 ()


  • General internal orthopaedic fixation system implantation kit

APEX Spine System - 00193082051838

Size-Neutral Caddy for Reduction Screws Dia.7.75 and Dia.8.5mm Screws
SPINECRAFT, LLC
6000-710-6
In Commercial Distribution

  • 00193082051838 ()
6000-710-6

  • General internal orthopaedic fixation system implantation kit

N/A - 04052536014255

Blade for distraction and compression forceps, fig. L, width 90 mm
Ulrich GmbH & Co. KG
CS 3032-09
In Commercial Distribution

  • 04052536014255 ()
CS 3032-09

  • General internal orthopaedic fixation system implantation kit

N/A - 04052536014248

Blade for distraction and compression forceps, fig. M, width 47 mm
Ulrich GmbH & Co. KG
CS 3032-08
In Commercial Distribution

  • 04052536014248 ()
CS 3032-08

  • General internal orthopaedic fixation system implantation kit

FAICO CMF System - 00840192716187

Mandibular Reconstruction System, Teflon Case Only for Screws and Plates. Empty
FAICO MEDICAL LLC
F2.7-998-110
Not in Commercial Distribution

  • 00840192716187 ()


  • General internal orthopaedic fixation system implantation kit

FAICO CMF System - 00840192716002

Fracture Plating System, Teflon Case Only for Screws and Plates. Empty
FAICO MEDICAL LLC
F2.3-998-110
Not in Commercial Distribution

  • 00840192716002 ()


  • General internal orthopaedic fixation system implantation kit

FAICO CMF System - 00840192715487

Miniplating - Low-Profile System, Teflon Case Only for Screws and Plates. Empty
FAICO MEDICAL LLC
FL2.0-998-110
Not in Commercial Distribution

  • 00840192715487 ()


  • General internal orthopaedic fixation system implantation kit

NA - 04250869652889

MOSS VRS T-handle for final tightener, 11Nm, 1/4" coupling, 132mm
Biedermann Motech GmbH & Co. KG
208-050-0410
In Commercial Distribution

  • 04250869652889 ()
208-050-0410

  • General internal orthopaedic fixation system implantation kit

ASTRA Spine System - 00193082121333

ASTRA Extra Short Regular Polyaxial Screwdriver Shaft for S2AI Screws, Trilobe End
SPINECRAFT, LLC
6300-89SAI-XSHT
In Commercial Distribution

  • 00193082121333 ()
6300-89SAI-XSHT

  • General internal orthopaedic fixation system implantation kit
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