510(k) K260660
- Device
- SABER-C System
- Applicant
- Elevation Spine
- 510(k) number
- K260660
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-27
- Date received
- 2026-03-02
- 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
Applicant Contact#
- Contact
- John Kirwan
- Address
- 2511 Garden Rd. Suite B125 Monteray CA US 93940 93940
FDA Registration Numbers#
- 3009888740
- 3010287685
- 3009217531
- 3005497913
- 3010057495
- 2027467
- 3004635447
- 1824199
- 3010047454
- 1226544
- 9681465
- 1833986
- 2031966
- 3021180147
- 3004188066
- 3008455034
- 3004499989
- 1834331
- 3010178296
- 3003761012
- 3006783837
- 3015398319
- 3017597868
- 1000461041
- 3010462278
- 3006846753
- 3005819474
- 3009882675
- 3036042032
- 3019767615
- 3005739886
- 3009973336
- 3003477135
- 3002807112
- 3025603301
- 3004893332
- 3004774118
- 3010197224
- 3012447612
- 3016084569
- 1526534
- 3019878714
- 1649518
- 3012120772
- 9615021
- 3012028003
- 3005031160
- 3010120326
- 3031081659
- 3012711663
- 3014680795
- 3013422238
- 3013055499
- 2647346
- 3007604895
- 3015991317
- 3014273501
- 3010705004
- 3017565094
- 1000432246
- 3013491327
- 3037407500
- 9615766
- 3010032903
- 3015941638
- 3018094310
- 2134285
- 3003855635
- 2532027
- 3009417901
- 3015869493
- 2028632
- 3013462427
- 3023189283
- 3008110533
- 3022295665
- 3043543260
- 2133928
- 1724955
- 3003525643
Source Documents#
Other 510(k) Records For Product Code OVE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026-08-21 |
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 |
| K262094 | E3D™-C Interbody System | Evolution Spine | 2026-07-22 |
| K261279 | DeltaNEC Interbody System | Nexus Spine | 2026-06-22 |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026-06-18 |
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026-06-15 |
| 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 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025-07-30 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 |