FDA product code MQZ: Prosthesis, Nail
MQZ is the FDA product code for prosthesis, nail. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under MQZ, 1 in the last five years, from 4 different applicants. The average 510(k) review took 322 days (median 266); 300 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Nail |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MQZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 593 |
| 2024 | 1 | 300 |
Compare with all 510(k) review times · Search every MQZ clearance
Top MQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jps Corporation | 1 | 2024-01-22 |
| Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | 1 | 2018-04-25 |
| European Touch Co., Inc. | 1 | 1996-08-12 |
| Inro Medical Designs, Inc. | 1 | 1985-10-16 |
Most recent MQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230841 | Jps Corporation | NailLift | 2024-01-22 | 300 |
| K162525 | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | Oniko nail brace | 2018-04-25 | 593 |
| K960843 | European Touch Co., Inc. | STOP-N-GROW | 1996-08-12 | 165 |
| K850803 | Inro Medical Designs, Inc. | NAIL SPLINT | 1985-10-16 | 231 |
Recalls for MQZ devices
openFDA lists no recalls for product code MQZ.
Frequently asked questions
What is FDA product code MQZ?
MQZ is the FDA product code for prosthesis, nail. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is MQZ?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MQZ?
Across 4 cleared submissions the average was 322 days from receipt to decision (median 266).
Which companies have the most MQZ clearances?
Jps Corporation (1); Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti (1); European Touch Co., Inc. (1); Inro Medical Designs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MQZ
- Run a recall and safety report across every MQZ manufacturer
- Watch product code MQZ 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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