Stealthfix Intraosseous Fixation System

GUDID 00810082894035

StealthFix Ti Implant 4.5mm Post x 20mm Span x 16mm Long

NEXTREMITY SOLUTIONS, INC.

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810082894035
• NIH Device Record Key: 93256d16-588b-4124-b206-67ec40e0c846
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealthfix Intraosseous Fixation System
• Version Model Number: SF452016
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810082894035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220181

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

[00810082894035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-12
• Device Publish Date: 2022-08-04

On-Brand Devices [Stealthfix Intraosseous Fixation System]

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