MySpine Cervical Guides
FDA 510(k) clearance K231515 · decided 2023-12-07
Clearance details
- K-number
- K231515
- Device name
- MySpine Cervical Guides
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-25
- Decision date
- 2023-12-07
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- QSD
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro, CH
- 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 |
|---|---|---|
| FIREFLY® Cervical Navigation Guide (K220132) | Mighty Oak Medical, Inc. | 2022-10-26 |
Recalls involving this device
No recalls on record reference this clearance.