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Instrument Set (case and Reusable Instruments)
FDA UDIClass II (US FDA UDI)
by Curvafix Inc
Identity
- Trade Name
- Instrument Set (case and Reusable Instruments) FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure. FDA UDI
- Model / Reference
- CIS-004 FDA UDI
- Description
- A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure. FDA UDI
Identifiers
- Catalog Number
- CIS-004 FDA UDI
- Primary DI / UDI-DI
- 10855068008737 FDA UDI
- 510(k) Number
- K222505 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Instrument Set (case and Reusable Instruments) by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K222505 also covers:
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Curvafix Inc
Sources (1)
- FDA UDI c201b832-3da4-414c-9b11-a56d838c8984 36 fields · synced Jun 8, 2026