Identity
- Trade Name
- IDENTITi NANOTEC FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- IDENTITi NANOTEC LIF POROUS Ti SPACER, 12 x 18 x 55 mm, 5° FDA UDI
- Model / Reference
- 100-PRO-12185505-S FDA UDI
- Description
- IDENTITi NANOTEC LIF POROUS Ti SPACER, 12 x 18 x 55 mm, 5° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376354569 FDA UDI
- 510(k) Number
- K211805 FDA UDI
- FDA Product Code
- PHM FDA UDIOVD FDA UDIMAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 55 Millimeter FDA UDIHeight — 12 Millimeter FDA UDIWidth — 18 Millimeter FDA UDIAngle — 5 degree FDA UDI
Category: Metallic spinal interbody fusion cage
IDENTITi NANOTEC by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K211805 also covers:
- IDENTITI NanoTec — ALPHATEC SPINE, INC.
- IDENTITI NanoTec — ALPHATEC SPINE, INC.
- IDENTITI NanoTec — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — ALPHATEC SPINE, INC.
- IDENTITi NANOTEC — 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 5dfbbadc-77bd-4fd9-9dd5-6474fd8667ea 36 fields · synced Jun 8, 2026