FDA Product Code QSR: Sacroiliac Screw Placement Guide
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.
Leading manufacturers include Medacta International S.A..
1
Total
1
Cleared
57d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Sacroiliac Screw Placement Guide Devices (Product Code QSR)
1 devices
About Product Code QSR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QSR since 2022, with 1 receiving FDA clearance (average review time: 57 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.