510(k) K231515
- Device
- MySpine Cervical Guides
- Applicant
- Medacta International S.A.
- 510(k) number
- K231515
- Product code
- QSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-07
- Date received
- 2023-05-25
- Regulation
- 888.3075
- Classification name
- Posterior Cervical Screw Placement Guide
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers#
- 3011818499
- 3005180920
- 3008110533
- 3006017180
Source Documents#
Other 510(k) Records For Product Code QSD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220132 | FIREFLY® Cervical Navigation Guide | Mighty Oak Medical, Inc. | 2022-10-26 |