QSR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sacroiliac Screw Placement Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (K220888) | Medacta International S.A. | 2022-05-24 | + Add |
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