Identity
- Trade Name
- Removal Tool FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- A hand-held stainless steel surgical instrument consisting of a square drive component and spanner component, each with set screws knobs, that interfaces with the CurvaFix Implant and the Core Wire in the Implant cannula for unlocking and removing the Implant. FDA UDI
- Model / Reference
- CRT-001 FDA UDI
- Description
- A hand-held stainless steel surgical instrument consisting of a square drive component and spanner component, each with set screws knobs, that interfaces with the CurvaFix Implant and the Core Wire in the Implant cannula for unlocking and removing the Implant. FDA UDI
Identifiers
- Catalog Number
- CRT-001 FDA UDI
- Primary DI / UDI-DI
- 10855068008775 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Removal Tool by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Curvafix Inc
Sources (1)
- FDA UDI dd439f8c-438b-4acd-8fba-49d534f26401 35 fields · synced Jun 8, 2026