Identity
- Trade Name
- Certex Spinal Fixation System FDA UDI
- Generic Name
- Orthopaedic rod reducer FDA UDI
- Device Name
- Rod Fork FDA UDI
- Model / Reference
- X067-0640 FDA UDI
- Description
- Rod Fork FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X06706401 FDA UDI
- FDA Product Code
- NKG FDA UDIKWP FDA UDI
- GMDN Term
- Orthopaedic rod reducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- Not 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
No
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
Certex Spinal Fixation System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI 30d8f06f-26aa-46ac-9b5f-b1d69ac5c8a2 35 fields · synced Jun 1, 2026