MJW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Subtalar, Plug, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 1992: 1 · 2002: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SUBTALAR PEG IMPLANT (K033046) | Nexa Orthopedics, Inc. | 2003-12-23 |
| LUNDEEN SUBTALAR PEG IMPLANT (K922292) | Sgarlato Laboratories, Inc. | 1992-10-23 |
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Every clearance here is in the API, with alerts when new ones post.