Posterior Cervical Screw Placement Guide
The Posterior Cervical Screw Placement Guide is a surgical instrument designed to assist surgeons in the accurate intraoperative placement of screws into the posterior elements of the cervical spine during posterior cervical fixation procedures. The device uses anatomical landmarks identified on preoperative imaging scans to guide screw trajectory. Classified as FDA Class 2 under regulation 888.3075, it requires 510(k) clearance in the Orthopedic specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSD
- Device Class
- FDA class 2
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.