510(k) K152099
- Device
- Genesys Spine Apache® Anchored Cervical Interbody Fusion System
- Applicant
- GENESYS SPINE
- 510(k) number
- K152099
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-28
- Date received
- 2015-07-28
- 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
- BEN KELLER
- Address
- 1250 Capital Of Texas Hwy. Bldg. 3, Suite 600 Austin TX US 78746 78746
FDA Registration Numbers#
- 3008583793
- 3005739886
- 3011577940
- 3005497913
- 3011181154
- 3015179588
- 3000203391
- 2648623
- 3009957608
- 3010197224
- 1935627
- 3012028003
- 3006783837
- 3004049923
- 3000270450
- 1220477
- 1724955
- 3013055499
- 2032098
- 3004024955
- 3010097171
- 9615766
- 2532027
- 1833986
- 2032093
- 3007125392
- 3010162973
- 3010032903
- 1219518
- 3010560653
- 3010120104
- 3007485169
- 3004638600
- 3017936978
- 3009217531
- 3009051471
- 3013413393
- 3002807112
- 3014655115
- 3006846753
- 3009380063
- 3003526896
- 3003639920
- 3022943642
- 3009887475
- 2531195
- 3010197239
- 3009756327
- 3004774118
- 3012428435
- 3025602479
- 3013491327
- 3011127597
- 3027807601
- 1423662
- 2133928
- 3009882675
- 1720929
- 9610612
- 3021180147
- 3006128100
- 1526711
- 3008992889
- 1319660
- 9681465
- 1450662
- 3009959868
- 3007766698
- 3009189869
- 3008455034
- 1424263
- 3037407500
- 3040266825
- 3005677016
- 9611813
- 9615021
- 3012711663
- 3016112537
- 3009888740
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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