Identity
- Trade Name
- SpineSmith IN:C2 Spinal Fixation System FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- IN:C2 Cervical System Kit w/stopless Trials - UDI not correct. Do Not Use FDA UDI
- Model / Reference
- 1110-0002-PL FDA UDI
- Description
- IN:C2 Cervical System Kit w/stopless Trials - UDI not correct. Do Not Use FDA UDI
Identifiers
- Catalog Number
- 1110-0002-PL FDA UDI
- Primary DI / UDI-DI
- 00817771029822 FDA UDI
- 510(k) Number
- K122630 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not 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
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
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
SpineSmith IN:C2 Spinal Fixation System by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122630 also covers:
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
- Celling Biosciences
Sources (1)
- FDA UDI 26ff4dbe-6fe1-4bb2-8833-518e81df3de0 37 fields · synced Jun 1, 2026