Identity
- Trade Name
- Novel FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- NOVEL-LCC 12 x 20 x 8mm LORDOSIS FDA UDI
- Model / Reference
- 64104-108 FDA UDI
- Description
- NOVEL-LCC 12 x 20 x 8mm LORDOSIS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844856008540 FDA UDI
- 510(k) Number
- K080699 FDA UDI
- FDA Product Code
- MQP FDA UDIMAX FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3080 FDA UDI
- Commercial Distribution
- 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
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
Dimensions & Sizes
- Size
- Length — 20 Millimeter FDA UDIHeight — 8 Millimeter FDA UDIWidth — 12 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cageVertebral body prosthesis
Novel by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vertebral body prosthesis.
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Cleared under the same submission
K080699 also covers:
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
- Novel — ALPHATEC SPINE, INC.
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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 2211b627-b510-4be7-b648-fcea6cb678ad 36 fields · synced Jun 8, 2026