K231515
- 510(k) number
- K231515
- Device name
- MySpine Cervical Guides
- Applicant
- Medacta International S.A. CH
- Product code
- QSD — Posterior Cervical Screw Placement Guide
- Decision date
- 2023-12-07
- Date received
- 2023-05-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231515.pdf
Official FDA record: K231515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.