NuFix II NFII-600C

GUDID B946NFII600C0

NuFix II Cannulated Blade Rev. 01

NUTECH SPINE, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device IDB946NFII600C0
NIH Device Record Key3f2ae362-3d92-42de-a35e-14dc4ca40848
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuFix II
Version Model Number01
Catalog NumberNFII-600C
Company DUNS080867996
Company NameNUTECH SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB946NFII600C0 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


[B946NFII600C0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

On-Brand Devices [NuFix II]

B946NFII600CIR0NuFix II Cannulated Blade
B946NFII600C0NuFix II Cannulated Blade Rev. 01
B946NFII6000NuFix II Non-Cannulated Blade
B946NFII500IR0NuFix II Inserter
B946NFII5000NuFix II Inserter Rev. 01
B946NFII4020NuFix II Drill, 5.0mm Rev. 01
B946NFII300IR0NuFix II Drill Guide
B946NFII3000NuFix II Drill Guide Rev. 01
B946NFII200IR0Drill Bushing Center Hole
B946NFII200DIR0Drill Bushing Two Holes
B946NFII200D0Drill Bushing Two Holes Rev. 01
B946NFII2000Drill Bushing Center Hole Rev. 01
B946024000070NuFix II Drill, 4.5mm - Stepped, Undersized
B946024000060NuFix II Drill, 4.5mm - Stepped
B946024000050NuFix II Drill, 4.5mm-Tapered, Undersized
B946024000040NuFix II Drill, 4.5mm - Tapered
B946024000030NuFix II Broach
B946024000010NuFix II Drill, 4.5mm
B946021000010NuFix II Go/No-Go Gage

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