510(k) K101588
- Device
- ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
- Applicant
- APOLLO SPINE, INC.
- 510(k) number
- K101588
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-07
- Date received
- 2010-06-07
- 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
- CHRISTINE SANTAGATE
- Address
- 75 Mill St. Stoughton MA US 02072 02072
FDA Registration Numbers#
- 3013491327
- 3009504230
- 1720929
- 2183946
- 3016460869
- 3005325790
- 3005497913
- 3025603301
- 3013413393
- 3007993775
- 3010123206
- 3016237080
- 3004638600
- 1220477
- 3011795235
- 9615766
- 3012711663
- 3015991317
- 3010032903
- 1424434
- 3010197239
- 1724955
- 9615800
- 3017597868
- 1835296
- 3009998573
- 9617297
- 3040266825
- 3004024955
- 3004893332
- 3004961578
- 3016084569
- 3010049501
- 3006404071
- 3009756327
- 3003526896
- 9610612
- 3018094310
- 1057425
- 3016443334
- 1834331
- 2530808
- 3010197224
- 1225492
- 3016112537
- 3006217744
- 3004153896
- 3015398319
- 1000517406
- 3010120135
- 3007485169
- 3011127597
- 3015876273
- 3011577940
- 3005076207
- 3010705004
- 3009380063
- 1319660
- 3009144915
- 3010178296
- 3009149199
- 3013422236
- 3015877656
- 2531195
- 3010863450
- 3030412764
- 3007210720
- 2032093
- 3005180920
- 3037407500
- 1833920
- 3010041430
- 3022295665
- 3006128100
- 3004635447
- 3005706667
- 3010047454
- 3009959868
- 1649518
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
Legacy Summary#
summary
FDA Review#
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