Identity
- Trade Name
- Cambria™ FDA UDI
- Generic Name
- Vertebral body prosthesis, non-sterile FDA UDI
- Device Name
- Cambria Implant, 17mm x 13mm x 7mm, Lordotic FDA UDI
- Model / Reference
- 39-1707 FDA UDI
- Description
- Cambria Implant, 17mm x 13mm x 7mm, Lordotic FDA UDI
Identifiers
- Catalog Number
- 39-1707 FDA UDI
- Primary DI / UDI-DI
- 10889981057954 FDA UDI
- 510(k) Number
- K052170 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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™ 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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Cleared under the same submission
K052170 also covers:
- Cambria™ — SeaSpine Orthopedics Corporation
- Cambria™ — SeaSpine Orthopedics Corporation
- Malibu — SeaSpine Orthopedics Corporation
- NewPort™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Pacifica — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Pacifica™ — 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 f3a6a563-fd7e-43d8-a054-053d4da3df64 37 fields · synced Jun 8, 2026