510(k) K260038
- Device
- E3D-C Interbody System
- Applicant
- Evolution Spine
- 510(k) number
- K260038
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-04
- Date received
- 2026-01-06
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Quynh Tran
- Address
- 2300 N. Haskell Ave. Dallas TX US 75204 75204
FDA Registration Numbers
- 3008850074
- 3013961579
- 9615800
- 3006128100
- 3009962553
- 3036042032
- 3006563559
- 2183449
- 9610612
- 3010041499
- 3010197224
- 9615021
- 1219518
- 1423662
- 3010329663
- 3000203391
- 9611813
- 3014937101
- 1724955
- 3009957608
- 3033509898
- 2648623
- 3008110533
- 3010047454
- 3007993775
- 3012711663
- 3015398319
- 3018094310
- 3009973505
- 3010863450
- 3021180147
- 3003597504
- 3008868758
- 2028632
- 2532027
- 1424434
- 3010287685
- 3010097171
- 3022295665
- 3013491327
- 2031966
- 3009756327
- 3009144915
- 3010363503
- 1000432246
- 3009189869
- 3010560653
- 1824199
- 8043792
- 3014680795
- 1057425
- 2531195
- 3004024955
- 3000170817
- 1220477
- 3009888740
- 3003761012
- 3005144609
- 3008812560
- 3009882675
- 3006783837
- 3008583793
- 3010047402
- 3016112537
- 3016460869
- 3015869493
- 3018210489
- 3005819474
- 3010160527
- 1000461041
- 3017528621
- 3005180920
- 3005031160
- 3000270450
- 8020776
- 3009417901
- 3005677016
- 3041915189
- 3011127597
- 3004188066
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 |
| 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 |
| 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 |