510(k) K231515
K231515 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MySpine Cervical Guides". The FDA issued a decision of Substantially Equivalent on December 7, 2023. The device falls under product code QSD (Posterior Cervical Screw Placement Guide), a Class II device regulated under 21 CFR 888.3075. Medacta International S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2023
- Date Received
- May 25, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Posterior Cervical Screw Placement Guide
- Device Class
- Class II
- Regulation Number
- 888.3075
- Review Panel
- OR
- Submission Type
A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.