Identity
- Trade Name
- IdentiTi FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- IDENTiTi PC POROUS Ti TRIAL, 9 x 9 x 35mm, 0° FDA UDI
- Model / Reference
- 123-09093500 FDA UDI
- Description
- IDENTiTi PC POROUS Ti TRIAL, 9 x 9 x 35mm, 0° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376246123 FDA UDI
- 510(k) Number
- K183705 FDA UDI
- FDA Product Code
- MAX FDA UDIPHM FDA UDI
- GMDN Term
- Spinal implant trial 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
Dimensions & Sizes
- Size
- Width — 9 Millimeter FDA UDIHeight — 9 Millimeter FDA UDILength — 35 Millimeter FDA UDI
Category: Spinal implant trial
IdentiTi by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal implant trial.
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- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- Yellowstone — Summit Spine · Class II
Cleared under the same submission
K183705 also covers:
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — ALPHATEC SPINE, INC.
- ATEC Porous Ti Interbody System — 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 dc7a8470-fe54-4b08-a0f5-64f07a90c37e 36 fields · synced Jun 8, 2026