QSD — Posterior Cervical Screw Placement Guide Class II
FDA product code QSD covers "Posterior Cervical Screw Placement Guide", a Class II medical device regulated under 21 CFR 888.3075. Submissions are reviewed by the Orthopedic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QSD
- Device Class
- Class II
- Regulation Number
- 888.3075
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
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.