FDA product code QSD: Posterior Cervical Screw Placement Guide
QSD is the FDA product code for posterior cervical screw placement guide. It is a Class II device, regulated under 21 CFR 888.3075 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QSD, 2 in the last five years, from 2 different applicants. The average 510(k) review took 238 days (median 238).
Definition
A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Classification
| Field | Value |
|---|---|
| Device name | Posterior Cervical Screw Placement Guide |
| Device class | Class II |
| Regulation | 21 CFR 888.3075 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QSD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 281 |
| 2023 | 1 | 196 |
Compare with all 510(k) review times · Search every QSD clearance
Top QSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medacta International S.A. | 1 | 2023-12-07 |
| Mighty Oak Medical, Inc. | 1 | 2022-10-26 |
Most recent QSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231515 | Medacta International S.A. | MySpine Cervical Guides | 2023-12-07 | 196 |
| K220132 | Mighty Oak Medical, Inc. | FIREFLY® Cervical Navigation Guide | 2022-10-26 | 281 |
Recalls for QSD devices
openFDA lists no recalls for product code QSD.
Frequently asked questions
What is FDA product code QSD?
QSD is the FDA product code for posterior cervical screw placement guide. It is a Class II device, regulated under 21 CFR 888.3075 and reviewed by the Orthopedic panel.
What device class is QSD?
Class II, regulation 21 CFR 888.3075. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSD?
Across 2 cleared submissions the average was 238 days from receipt to decision (median 238).
Which companies have the most QSD clearances?
Medacta International S.A. (1); Mighty Oak Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSD
- Run a recall and safety report across every QSD manufacturer
- Watch product code QSD 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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