Identity
- Trade Name
- OneLIF™ FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Trial-OneLIF Interbody, Medium, 25 Degree, 18mm X 7mm FDA UDI
- Model / Reference
- 011-225-1807 FDA UDI
- Description
- Trial-OneLIF Interbody, Medium, 25 Degree, 18mm X 7mm FDA UDI
Identifiers
- Catalog Number
- 011-225-1807 FDA UDI
- Primary DI / UDI-DI
- G07001122518070 FDA UDI
- 510(k) Number
- K211769 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX 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
No
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
Category: Spinal implant trial
A comprehensive intervertebral fusion device with integrated fixation, designed for orthopedic use. OneLIF is a medium-sized implant used to stabilize the spine and promote healing.
Similar devices
Also classified as Spinal implant trial.
- Novel — ALPHATEC SPINE, INC. · Class II
- Scarlet AL-T Instruments — Spineart · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- MLX — Nuvasive, Inc. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- ROI-A — Ldr Spine USA · Class II
Cleared under the same submission
K211769 also covers:
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
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
- Novapproach Spine
Sources (1)
- FDA UDI 902e5014-4ebd-4d4c-9bfe-6e1ead27ce9d 36 fields · synced Jul 24, 2026