COALITION SPACER
FDA 510(k) clearance K083389 · decided 2009-03-26
Clearance details
- K-number
- K083389
- Device name
- COALITION SPACER
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-17
- Decision date
- 2009-03-26
- Days to decision
- 129 days
- Clearance type
- Special
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZSAlign Cervical Interbody System (K261451) | ZSFab, Inc. | 2026-07-31 |
| E3D™-C Interbody System (K262094) | Evolution Spine | 2026-07-22 |
| DeltaNEC Interbody System (K261279) | Nexus Spine | 2026-06-22 |
| CONDUIT™ ZERO-P™ VA Secured Spacer System (K252982) | Avalign Technologies, Inc. | 2026-06-18 |
| NeckTune™ 3D SA Cervical Cage (K260036) | Medyssey Co, Ltd. | 2026-06-15 |
| SABER-C System (K260660) | Elevation Spine | 2026-04-27 |
| SAGI Cervical Cage System (K253213) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| Uni-C Cervical Cage System (K252774) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| E3D™-C Interbody System (K260038) | Evolution Spine | 2026-02-04 |
| HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) | Globus Medical, Inc. | 2025-12-22 |
| Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200) | 4Web Medical, Inc. | 2025-12-11 |
| Endeavor™ Stand-Alone Cervical IBF System (K250076) | Innovasis | 2025-09-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |