StealthFix Intraosseous Fixation System

GUDID 00810082898606

StealthFix Small Drill Saw Guide LowPro

Medartis Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810082898606
• NIH Device Record Key: 325e2ef4-13fb-4e2a-beaf-e1cef6e48049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthFix Intraosseous Fixation System
• Version Model Number: SF2302
• Company DUNS: 192756786
• Company Name: Medartis 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00810082898606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232324

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

[00810082898606]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [StealthFix Intraosseous Fixation System]

• 00810082898644: StealthFix STD Implant Tamp
• 00810082898637: StealthFix Small Implant Tamp
• 00810082898620: StealthFix STD 20 Guide LowPro
• 00810082898613: StealthFix STD 15 Drill Saw Guide LowPro
• 00810082898606: StealthFix Small Drill Saw Guide LowPro
• 00810082898590: StealthFix Non-sterile 150mm K-wire Cage
• 00810082898583: StealthFix Non-sterile 100mm K-wire Cage
• 00810082898576: StealthFix Non-sterile Implant Caddy Lid
• 00810082898569: StealthFix Non-sterile Implant Caddy
• 00810082898552: StealthFix Non-sterile Instrument Lid
• 00810082898545: StealthFix Non-sterile Instrument Case
• 00810082898163: StealthFix Fully Threaded Headless Screw Size 26
• 00810082898156: StealthFix Fully Threaded Headless Screw Size 24
• 00810082898149: StealthFix Fully Threaded Headless Screw Size 22
• 00810082898132: StealthFix Fully Threaded Headless Screw Size 20
• 00810082898125: StealthFix Fully Threaded Headless Screw Size 18
• 00810082898118: StealthFix Fully Threaded Headless Screw Size 16
• 00810082898101: StealthFix Fully Threaded Headed Screw Size 38
• 00810082898095: StealthFix Fully Threaded Headed Screw Size 36
• 00810082898088: StealthFix Fully Threaded Headed Screw Size 34
• 00810082898071: StealthFix Fully Threaded Headed Screw Size 32
• 00810082898064: StealthFix Fully Threaded Headed Screw Size 30
• 00810082898057: StealthFix Fully Threaded Headed Screw Size 28
• 00810082898040: StealthFix Fully Threaded Headed Screw Size 26
• 00810082898033: StealthFix Fully Threaded Headed Screw Size 24
• 00810082898026: StealthFix Fully Threaded Headed Screw Size 22
• 00810082898019: StealthFix Fully Threaded Headed Screw Size 20
• 00810082898002: StealthFix Fully Threaded Headed Screw Size 18
• 00810082894523: StealthFix Fully Threaded Headed Screw Size 16
• 00810082894295: StealthFix Fully Threaded Headless Screw Size 38
• 00810082894288: StealthFix Fully Threaded Headless Screw Size 36
• 00810082894271: StealthFix Fully Threaded Headless Screw Size 34
• 00810082894264: StealthFix Fully Threaded Headless Screw Size 32
• 00810082894257: StealthFix Fully Threaded Headless Screw Size 30
• 00810082894240: StealthFix Fully Threaded Headless Screw Size 28