DeviceClearance

Product code QSR— Orthopedic

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

Classification name
Sacroiliac Screw Placement Guide
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.”

— U.S. Food and Drug Administration, device classification record for product code QSR under 21 CFR 888.3040, via openFDA

Market context for product code QSR

FDA has cleared 1 device under product code QSR, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSR

Recent clearances under product code QSR

Data sourced from openFDA. This site is unofficial and independent of the FDA.