FDA product code QSR: Sacroiliac Screw Placement Guide
QSR is the FDA product code for sacroiliac screw placement guide. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QSR, 1 in the last five years. The average 510(k) review took 57 days (median 57).
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.
Classification
| Field | Value |
|---|---|
| Device name | Sacroiliac Screw Placement Guide |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QSR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 57 |
Compare with all 510(k) review times · Search every QSR clearance
Top QSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medacta International S.A. | 1 | 2022-05-24 |
Most recent QSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220888 | Medacta International S.A. | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | 2022-05-24 | 57 |
Recalls for QSR devices
openFDA lists no recalls for product code QSR.
Frequently asked questions
What is FDA product code QSR?
QSR is the FDA product code for sacroiliac screw placement guide. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is QSR?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSR?
Across 1 cleared submissions the average was 57 days from receipt to decision (median 57).
Which companies have the most QSR clearances?
Medacta International S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSR
- Run a recall and safety report across every QSR manufacturer
- Watch product code QSR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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