QSD — Posterior Cervical Screw Placement Guide Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231515medacta internationalMySpine Cervical GuidesDecember 7, 2023
K220132mighty oak medicalFIREFLY® Cervical Navigation GuideOctober 26, 2022