Identity
- Trade Name
- OneLIF™ FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Bone Screw, Self-Drilling, 4.5 mm, 28 mm FDA UDI
- Model / Reference
- 012-001-4528 FDA UDI
- Description
- Bone Screw, Self-Drilling, 4.5 mm, 28 mm FDA UDI
Identifiers
- Catalog Number
- 012-001-4528 FDA UDI
- Primary DI / UDI-DI
- G07001200145280 FDA UDI
- 510(k) Number
- K211769 FDA UDI
- FDA Product Code
- MAX FDA UDIOVD FDA UDI
- GMDN Term
- Spinal bone screw, 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
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
Category: Spinal bone screw, non-bioabsorbable
OneLIF™ by Novapproach Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · 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 |
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Manufacturer
- Manufacturer
- Novapproach Spine
Sources (1)
- FDA UDI ff77df7f-c20e-4b2e-8035-89a3dc8be81c 36 fields · synced Jun 1, 2026