FDA product code MRI: Orthosis, Truncal/Orthosis, Limb
MRI is the FDA product code for orthosis, truncal/orthosis, limb. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under MRI, from 2 different applicants. The average 510(k) review took 802 days (median 802).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Truncal/Orthosis, Limb |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top MRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R. Thomas Grotz, M.D., Inc. | 1 | 1997-11-03 |
| Mopac, Ltd. | 1 | 1996-09-30 |
Most recent MRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973031 | R. Thomas Grotz, M.D., Inc. | STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE | 1997-11-03 | 81 |
| K923880 | Mopac, Ltd. | ORLAU SWIVEL WALKER | 1996-09-30 | 1522 |
Recalls for MRI devices
openFDA lists no recalls for product code MRI.
Frequently asked questions
What is FDA product code MRI?
MRI is the FDA product code for orthosis, truncal/orthosis, limb. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is MRI?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MRI?
Across 2 cleared submissions the average was 802 days from receipt to decision (median 802).
Which companies have the most MRI clearances?
R. Thomas Grotz, M.D., Inc. (1); Mopac, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MRI
- Run a recall and safety report across every MRI manufacturer
- Watch product code MRI 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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