Identity
- Trade Name
- Stealthfix Intraosseous Fixation System FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- StealthFix Ti Implant 4.5mm Post x 20mm Span x 26mm Long FDA UDI
- Model / Reference
- SF452026 FDA UDI
- Description
- StealthFix Ti Implant 4.5mm Post x 20mm Span x 26mm Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810082894080 FDA UDI
- 510(k) Number
- K220181 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Stealthfix Intraosseous Fixation System by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone staple, non-adjustable.
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- JAWS Nitinol Staple System — Paragon 28 · Class II
Cleared under the same submission
K220181 also covers:
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
- Stealthfix Intraosseous Fixation System — Medartis Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (1)
- FDA UDI a22ae863-622a-4349-8eac-a90cdf9e871f 34 fields · synced Jun 8, 2026