ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
FDA 510(k) clearance K210035 · decided 2021-02-16
Clearance details
- K-number
- K210035
- Device name
- ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
- Applicant
- Aegis Spine
- Decision
- Substantially Equivalent
- Date received
- 2021-01-06
- Decision date
- 2021-02-16
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- OUR
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, 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 |
|---|---|---|
| CATAMARAN™ SI Joint Fusion System (K260477) | Tenon Medical | 2026-04-08 |
| iFuse INTRA Ti™ Implant System (K253488) | SI-BONE, Inc. | 2026-02-11 |
| Falco Fusion System (K253611) | Mcnicoll Surgical, Inc. | 2026-01-29 |
| Sacroiliac Joint Truss System (SJTS) (K252834) | 4Web Medical | 2026-01-28 |
| OptumSI Implant System (K251365) | Si Solutions, LLC | 2025-11-20 |
| SIros-X System (K252322) | Genesys Spine | 2025-10-22 |
| iFuse Bedrock Granite Implant System (K253094) | SI-BONE, Inc. | 2025-10-09 |
| Eminent Spine Posterior SI System (K250894) | Eminent Spine | 2025-10-07 |
| SImmetry+ System (K250647) | Sivantage | 2025-07-29 |
| panaSIa SI Fusion System (K250247) | Wenzel Spine, Inc. | 2025-07-09 |
| The Rialto™ SI Fusion System (K251395) | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| Omnia Medical PsiF DNA™ System (K242431) | Omnia Medical, LLC | 2025-06-06 |
Recalls involving this device
No recalls on record reference this clearance.