Identity
- Trade Name
- LIF AMP FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE FDA UDI
- Model / Reference
- 116-2-52-04-S FDA UDI
- Description
- LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376423210 FDA UDI
- 510(k) Number
- K211805 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Category: Spinal bone screw, non-bioabsorbableSpinal fixation plate, non-bioabsorbable
Lif Amp by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI c2007755-52ec-413d-9f8d-937178f20c09 35 fields · synced Jun 8, 2026