QSR — Sacroiliac Screw Placement Guide Class II
FDA product code QSR covers "Sacroiliac Screw Placement Guide", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QSR
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220888 | medacta international | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | May 24, 2022 |