FDA product code MNF: Implant, Temporal
MNF is the FDA product code for implant, temporal. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under MNF, from 2 different applicants. The average 510(k) review took 122 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Implant, Temporal |
| Device class | Class II |
| Regulation | 21 CFR 878.3550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MNF clearance
Top MNF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteosymbionics, LLC | 1 | 2011-09-22 |
| Porex Surgical Products Group | 1 | 2000-11-17 |
Most recent MNF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111069 | Osteosymbionics, LLC | OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT | 2011-09-22 | 157 |
| K002586 | Porex Surgical Products Group | MEDPOR PTERIONAL SURGICAL IMPLANT | 2000-11-17 | 88 |
Recalls for MNF devices
openFDA lists no recalls for product code MNF.
Frequently asked questions
What is FDA product code MNF?
MNF is the FDA product code for implant, temporal. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel.
What device class is MNF?
Class II, regulation 21 CFR 878.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNF?
Across 2 cleared submissions the average was 122 days from receipt to decision (median 122).
Which companies have the most MNF clearances?
Osteosymbionics, LLC (1); Porex Surgical Products Group (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MNF
- Run a recall and safety report across every MNF manufacturer
- Watch product code MNF 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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