510(k) K251735
- Device
- Stabilis SA Cervical Stand-Alone System (Various PNs)
- Applicant
- Acuity Surgical Devices, LLC
- 510(k) number
- K251735
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-30
- Date received
- 2025-06-06
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chuck Forton
- Address
- 8710 N. Royal Ln. Irving TX US 75063 75063
FDA Registration Numbers
- 1423662
- 1450662
- 2133928
- 3005180920
- 3012131184
- 3013820501
- 3009241418
- 2530808
- 3006404071
- 3009394448
- 3010197239
- 2134470
- 3010057495
- 1000461041
- 3014655115
- 2031917
- 3011127597
- 3010041430
- 3007210720
- 2183946
- 3023852420
- 1834331
- 2032098
- 3000203391
- 1824199
- 3015212339
- 3009962553
- 3010197224
- 3005325790
- 1833920
- 3025603301
- 3003855635
- 3002807112
- 3016112537
- 3004142400
- 3009504230
- 2028632
- 3016460869
- 9610612
- 3000170817
- 3010032903
- 1319660
- 2532027
- 3010120104
- 3005819474
- 3017521423
- 3010162973
- 3013961579
- 3004635447
- 1424434
- 3012428435
- 9611390
- 3016443334
- 3004153896
- 3009756327
- 3014680795
- 3005031160
- 3025602479
- 3010863450
- 3019767615
- 3015216945
- 3016438694
- 8020776
- 3009973336
- 3008110533
- 3012028003
- 3010097171
- 9615800
- 3006128100
- 3019837678
- 3015398319
- 3005739886
- 3017936978
- 1649518
- 9681465
- 1030489
- 3007604895
- 2032093
- 3017528621
- 3009217531
Source Documents
Other 510(k) Records For Product Code OVE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260660 | SABER-C System | Elevation Spine | 2026-04-27 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| K260038 | E3D-C Interbody System | Evolution Spine | 2026-02-04 |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. | 2025-12-22 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 |
| K250076 | Endeavor Stand-Alone Cervical IBF System | Innovasis | 2025-09-25 |
| K250540 | SABER-C System | Elevation Spine | 2025-08-08 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | 2025-02-11 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | 2025-02-07 |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024-11-20 |
| K241846 | E3D-C Interbody System | Evolution Spine | 2024-08-12 |