Identity
- Trade Name
- Cambria™ NanoMetalene® FDA UDI
- Generic Name
- Vertebral body prosthesis, non-sterile FDA UDI
- Device Name
- Cambria NM Implant, 15x13, 12mm, Flat, Lordotic FDA UDI
- Model / Reference
- 39-2612 FDA UDI
- Description
- Cambria NM Implant, 15x13, 12mm, Flat, Lordotic FDA UDI
Identifiers
- Catalog Number
- 39-2612 FDA UDI
- Primary DI / UDI-DI
- 10889981064976 FDA UDI
- 510(k) Number
- K142488 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Vertebral body prosthesis, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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
Category: Vertebral body prosthesis, non-sterile
Cambria™ NanoMetalene® by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vertebral body prosthesis, non-sterile.
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- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
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Cleared under the same submission
K142488 also covers:
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
- Cambria™ NanoMetalene® — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 5bf17292-04fd-45ff-89e6-e74b8d6f69f4 37 fields · synced Jun 8, 2026