FDA product code MNU: Staple, Absorbable
MNU is the FDA product code for staple, absorbable. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under MNU, 3 in the last five years, from 2 different applicants. The average 510(k) review took 82 days (median 60); 58 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Staple, Absorbable |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MNU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 158 |
| 2023 | 1 | 48 |
| 2024 | 1 | 58 |
Compare with all 510(k) review times · Search every MNU clearance
Top MNU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| OSSIO , Ltd. | 3 | 2024-08-28 |
| Arthrex, Inc. | 1 | 2001-06-19 |
Most recent MNU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241932 | OSSIO , Ltd. | OSSIOfiber® Compression Staple | 2024-08-28 | 58 |
| K233302 | OSSIO , Ltd. | OSSIOfiber® Compression Staple | 2023-11-16 | 48 |
| K212594 | OSSIO , Ltd. | OSSIOfiber® Staple | 2022-01-21 | 158 |
| K011172 | Arthrex, Inc. | ARTHREX BIO-TRANSFIX | 2001-06-19 | 63 |
Recalls for MNU devices
openFDA lists no recalls for product code MNU.
Frequently asked questions
What is FDA product code MNU?
MNU is the FDA product code for staple, absorbable. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is MNU?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNU?
Across 4 cleared submissions the average was 82 days from receipt to decision (median 60).
Which companies have the most MNU clearances?
OSSIO , Ltd. (3); Arthrex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MNU
- Run a recall and safety report across every MNU manufacturer
- Watch product code MNU 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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