FDA product code MJW: Prosthesis, Subtalar, Plug, Polymer
MJW is the FDA product code for prosthesis, subtalar, plug, polymer. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under MJW, from 2 different applicants. The average 510(k) review took 123 days (median 123).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Subtalar, Plug, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MJW clearance
Top MJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nexa Orthopedics, Inc. | 1 | 2003-12-23 |
| Sgarlato Laboratories, Inc. | 1 | 1992-10-23 |
Most recent MJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033046 | Nexa Orthopedics, Inc. | SUBTALAR PEG IMPLANT | 2003-12-23 | 85 |
| K922292 | Sgarlato Laboratories, Inc. | LUNDEEN SUBTALAR PEG IMPLANT | 1992-10-23 | 161 |
Recalls for MJW devices
openFDA lists no recalls for product code MJW.
Frequently asked questions
What is FDA product code MJW?
MJW is the FDA product code for prosthesis, subtalar, plug, polymer. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is MJW?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJW?
Across 2 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most MJW clearances?
Nexa Orthopedics, Inc. (1); Sgarlato Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJW
- Run a recall and safety report across every MJW manufacturer
- Watch product code MJW 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times