510(k) K241846
- Device
- E3D?-C Interbody System
- Applicant
- Evolution Spine
- 510(k) number
- K241846
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-12
- Date received
- 2024-06-26
- 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
- No
Applicant Contact#
- Contact
- Todd Wallenstein
- Address
- 2300 N. Haskell Ave. Dallas TX US 75204 75204
FDA Registration Numbers#
- 3007766698
- 3043543260
- 3017521423
- 3012131184
- 3007604895
- 3019878714
- 3010120135
- 3033739814
- 3006404071
- 3015399803
- 3009962553
- 3010160527
- 3005739886
- 1649379
- 3022943642
- 3009882675
- 3022295665
- 1423662
- 3010097171
- 3008455034
- 3008526708
- 1835251
- 3000170817
- 1000432246
- 9615800
- 2031917
- 3023852420
- 1833920
- 9615766
- 3013961579
- 3016237080
- 1424263
- 3004024955
- 3040266825
- 3015398319
- 3005180920
- 8020776
- 3005031160
- 2032093
- 3007922509
- 3006017180
- 3011127597
- 2134285
- 3005325790
- 3010049501
- 3021180147
- 3004153896
- 1835296
- 1057425
- 3030412764
- 3003597504
- 3000270450
- 3011577940
- 3007993775
- 3015941638
- 3018094310
- 3003526896
- 3009887475
- 3012428435
- 3004774118
- 3009144915
- 3003761012
- 3011390763
- 3003855635
- 3007210720
- 3005819474
- 3003898943
- 3010009693
- 1000461041
- 2532027
- 3004893332
- 3009973336
- 3015877656
- 3013820501
- 3005596514
- 3010123206
- 3010370500
- 3011181154
- 3015991317
- 9681465
Source Documents#
Other 510(k) Records For Product Code OVE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263049 | SABER-C System | Elevation Spine | 2026-09-23 |
| 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 |
| 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 |