PQC · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3070
Classification
FDA Product Code
PQC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3070
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.