QSD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3075
Classification
FDA Product Code
QSD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3075
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.