CERVICAL STAND ALONE SYSTEM
FDA 510(k) clearance K132999 · decided 2014-04-14
Clearance details
- K-number
- K132999
- Device name
- CERVICAL STAND ALONE SYSTEM
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-24
- Decision date
- 2014-04-14
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lewisville, TX, 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 |
|---|---|---|
| CervicalStim® (P030034/S017) | Orthofix, Inc. | 2022-06-14 |
| PhysioStim®, SpinalStim® (P850007/S046) | Orthofix, Inc. | 2022-06-14 |
| SpinalStim (P850007/S044) | Orthofix, Inc. | 2020-03-27 |
| CervicalStim (P030034/S015) | Orthofix, Inc. | 2019-10-08 |
| PhysioStim and SpinalStim (P850007/S043) | Orthofix, Inc. | 2019-10-08 |
| SpinalStim (P850007/S042) | Orthofix, Inc. | 2019-07-03 |
| PhysioStim and SpinalStim (P850007/S041) | Orthofix, Inc. | 2019-06-18 |
| CervicalStim (P030034/S014) | Orthofix, Inc. | 2019-06-18 |