COROENT INTERLOCK SYSTEM
FDA 510(k) clearance K102547 · decided 2011-02-07
Clearance details
- K-number
- K102547
- Device name
- COROENT INTERLOCK SYSTEM
- Applicant
- Nuvasive, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-03
- Decision date
- 2011-02-07
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, 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 |
|---|---|---|
| Simplify® Cervical Artificial Disc (P200022/S016) | Nuvasive, Inc. | 2025-06-05 |
| Simplify® Cervical Artificial Disc (P200022/S017) | Nuvasive, Inc. | 2025-05-29 |
| Simplify Disc (P200022/S012) | Nuvasive, Inc. | 2025-02-18 |
| Simplify Cervical Artificial Disc (P200022/S015) | Nuvasive, Inc. | 2025-02-13 |
| Simplify Cervical Artificial Disc (P200022/S014) | Nuvasive, Inc. | 2024-12-18 |
| Simplify® Cervical Artificial Disc (P200022/S013) | Nuvasive, Inc. | 2024-04-17 |
| Simplify Disc (P200022/S011) | Nuvasive, Inc. | 2023-06-09 |
| Simplify Cervical Artificial Disc (P200022/S010) | Nuvasive, Inc. | 2023-03-15 |