MNU
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Staple, Absorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2004: 5 · 2005: 11 · 2006: 4
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 |
|---|---|---|
| OSSIOfiber® Compression Staple (K241932) | OSSIO , Ltd. | 2024-08-28 |
| OSSIOfiber® Compression Staple (K233302) | OSSIO , Ltd. | 2023-11-16 |
| OSSIOfiber® Staple (K212594) | OSSIO , Ltd. | 2022-01-21 |
| ARTHREX BIO-TRANSFIX (K011172) | Arthrex, Inc. | 2001-06-19 |
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Every clearance here is in the API, with alerts when new ones post.