510(k) K231515
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.