Identity
- Trade Name
- Instrument Set 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 surgical procedure for the CurvaFix IM Implant. FDA UDI
- Model / Reference
- CIS-001 FDA UDI
- Description
- A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a surgical procedure for the CurvaFix IM Implant. FDA UDI
Identifiers
- Catalog Number
- CIS-001 FDA UDI
- Primary DI / UDI-DI
- 10855068008416 FDA UDI
- FDA Product Code
- HWC FDA UDIHSB 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 UDI888.3020 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
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 surgical procedure kit, non-medicated, reusable
Instrument Set by Curvafix Inc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Curvafix Inc
Sources (1)
- FDA UDI b30e553a-3729-4619-9ef9-c5bb9497cdb3 35 fields · synced Jun 6, 2026