510(k) K251459
- Device
- OneLIF Interbody Fusion System
- Applicant
- Novapproach Spine, LLC
- 510(k) number
- K251459
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-12
- Date received
- 2025-05-12
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ron Green
- Address
- 13900 Tech City Cir. Suite 300 Alachua FL US 32615 32615
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3014967969
- 2133928
- 3005180920
- 3012131184
- 3013820501
- 3009241418
- 2530808
- 3006404071
- 3006639944
- 2027062
- 3010197239
- 3009973699
- 3010386387
- 3039167712
- 2134470
- 3010057495
- 3014655115
- 3014252644
- 3011127597
- 2183744
- 3010041430
- 3004717358
- 3006791286
- 2183946
- 3023852420
- 1834331
- 2032098
- 1824199
- 3015212339
- 3013194153
- 3009962553
- 3010197224
- 3004112448
- 1833920
- 3025603301
- 2032521
- 3005061536
- 3016112537
- 3013758617
- 3004142400
- 3009504230
- 2028632
- 3016460869
- 9610612
- 1526439
- 3003637761
- 3000170817
- 3010370554
- 3010032903
- 1319660
- 3015882686
- 2532027
- 3010120104
- 3005819474
- 3010162973
- 3004635447
- 1424434
- 3012428435
- 3008773560
- 2135156
- 9611390
- 3016443334
- 3004153896
- 3009756327
- 3014680795
- 3005031160
- 3010863450
- 3019767615
- 3005641619
- 3010531069
- 3006694268
- 3015216945
- 3016438694
- 8020776
- 3009973336
- 3008110533
- 3012028003
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code OVD
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024-10-29 |