Stealthfix Intraosseous Fixation System

GUDID 00810082894004

StealthFix Ti Implant 4.5mm Post x 15mm Span x 30mm Long

NEXTREMITY SOLUTIONS, INC.

Orthopaedic bone staple, non-adjustable
Primary Device ID00810082894004
NIH Device Record Key15499031-f553-4dcc-8a63-776553151449
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthfix Intraosseous Fixation System
Version Model NumberSF451530
Company DUNS060783407
Company NameNEXTREMITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100810082894004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


[00810082894004]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-12
Device Publish Date2022-08-04

On-Brand Devices [Stealthfix Intraosseous Fixation System]

00810082897562StealthFix STD 20 Position Guide
00810082897555StealthFix STD 15 Position Guide
00810082897418StealthFix Non-Sterile Kit
00810082897364StealthFix Ratcheting Handle
00810082897357StealthFix Small Position Guide
00810082897333K Wire 2.0mm X 100mm
00810082897326K Wire 1.6mm X 100mm
00810082897319K-Wire 1.6mm X 150mm
00810082896510StealthFix Guide Slide Small
00810082896503StealthFix Removal Rod, Small and Standard
00810082896480StealthFix Slap Hammer
00810082896428StealthFix Universal Post Depth Gauge
00810082896404StealthFix Hex Driver 2.5mm
00810082896398StealthFix Hex Driver 2.0mm
00810082896374StealthFix Post Drill 4.5mm
00810082896367StealthFix Post Drill 3.5mm
00810082896343StealthFix Screw Drill 2.5mm
00810082896336StealthFix Saw Sleeve 4.5mm X 20mm
00810082896329StealthFix Saw Sleeve 4.5mm X 15mm
00810082896312StealthFix Guide Slide 4.5mm
00810082896305StealthFix Drill Guide 4.5mm X 20mm
00810082896299StealthFix Drill Guide 4.5mm X 15mm
00810082896282StealthFix Drill Guide 3.5mm X 15mm
00810082896268StealthFix Screw Sleeve
00810082896251StealthFix Drill Sleeve
00810082896244StealthFix K-Wire Sleeve
00810082896237StealthFix Joint Gauge 4.5mm
00810082896220StealthFix Joint Gauge 3.5mm
00810082896213StealthFix Screw Depth Gauge
00810082896169StealthFix Saw Blade, Stryker 1mm X 43mm
00810082896138StealthFix Inserter 4.5mm X 20mm
00810082896121StealthFix Inserter 4.5mm X 15mm
00810082896114StealthFix Inserter 3.5mm
00810082896091StealthFix Impactor Long Handle
00810082896077StealthFix Targeting Guide Deep
00810082896060StealthFix Targeting Guide Shallow
00810082894233StealthFix Lag Screw 3.5mm x 38mm
00810082894226StealthFix Lag Screw 3.5mm x 36mm
00810082894219StealthFix Lag Screw 3.5mm x 34mm
00810082894202StealthFix Lag Screw 3.5mm x 32mm
00810082894196StealthFix Lag Screw 3.5mm x 30mm
00810082894189StealthFix Lag Screw 3.5mm x 28mm
00810082894172StealthFix Lag Screw 3.5mm x 26mm
00810082894165StealthFix Lag Screw 3.5mm x 24mm
00810082894158StealthFix Lag Screw 3.5mm x 22mm
00810082894141StealthFix Lag Screw 3.5mm x 20mm
00810082894134StealthFix Lag Screw 3.5mm x 18mm
00810082894127StealthFix Lag Screw 3.5mm x 16mm
00810082894110StealthFix Ti Implant 4.5mm Post x 20mm Span x 32mm Long
00810082894103StealthFix Ti Implant 4.5mm Post x 20mm Span x 30mm Long

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