Data / Medical devices / United States / Novapproach Spine, LLC
Novapproach Spine, LLC: FDA-registered device maker in Alachua, FL, United States, 1 510(k) clearance
Novapproach Spine, LLC is registered with the FDA (registration 3020307303) in Alachua, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 7, 2021. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020307303
- Address
- 13900 Tech City Circle Suite 300, Alachua, FL, United States, 32615
- Owner or operator
- NovApproach Spine, LLC (10082697)
- Roles
- Specification developer
- First device listed
- September 12, 2021
- Registered through
- 2027
- Brand names listed
- OneLIF Interbody Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 7, 2021 | K211769 | OneLIF Intervertebral Body Replacement System | OVD | Substantially Equivalent | Novapproach Spine | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2026 | 98835 | Class II | Ongoing | OneLIF Interbody Cage (REF/Description): /Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, /Small 7 Degree 12mm X 9mm, /Small 7 Degree 14mm X 11mm, /Small 7 Degree 16mm X 13mm, /Small, 13 De | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant. | accessdata.fda.gov |
| October 12, 2022 | 91016 | Class II | Terminated | OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS. | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
Updated May 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.