OneLIF Intervertebral Body Replacement System
FDA 510(k) clearance K211769 · decided 2021-09-07
Clearance details
- K-number
- K211769
- Device name
- OneLIF Intervertebral Body Replacement System
- Applicant
- Novapproach Spine
- Decision
- Substantially Equivalent
- Date received
- 2021-06-08
- Decision date
- 2021-09-07
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1 recall (Z-2213-2026) | Novapproach Spine, LLC | 2026-05-20 |
| OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a compo recall (Z-0246-2023) | Novapproach Spine LLC | 2022-11-17 |