510(k) K153250
- Device
- Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
- Applicant
- RENOVIS SURGICAL TECHNOLOGIES
- 510(k) number
- K153250
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-16
- Date received
- 2015-11-09
- 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
- ANTHONY DEBENEDICTIS
- Address
- 1901 W. Lugonia Redlands CA US 92374 92374
FDA Registration Numbers#
- 3010057495
- 1649518
- 3010197239
- 3010370500
- 3012428435
- 1529009
- 2531195
- 3009962553
- 3010329663
- 3036042032
- 3009144915
- 3005497913
- 3009957608
- 3015877656
- 3003525643
- 2028632
- 3043543260
- 3004188066
- 3016084569
- 9615766
- 3010560653
- 3006783837
- 3013462427
- 3008583793
- 8020776
- 3009380063
- 3004719693
- 3048284429
- 1834379
- 3015216945
- 3010162973
- 3015179588
- 3030412764
- 3019837678
- 3010363503
- 3025603301
- 3000203391
- 3011181154
- 3015398319
- 3017565094
- 3007210720
- 3012120772
- 3040266825
- 9681465
- 3017521423
- 2031917
- 3012764194
- 3003898943
- 3009882675
- 1833986
- 3010120135
- 2530808
- 1835296
- 3006128100
- 3012028003
- 3008992889
- 2031966
- 3011127597
- 3003120897
- 3006846753
- 3009959868
- 3041915189
- 3004961578
- 3004499989
- 1225492
- 3003387384
- 3017528621
- 3010120104
- 3005677016
- 3013413393
- 3025457095
- 3027807601
- 3009554293
- 3009217531
- 1000517406
- 1000461041
- 3007766698
- 3010041499
- 3019767615
- 3022295665
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-10-02 |
| K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | 2026-09-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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