Rotium
FDA 510(k) clearance K250021 · decided 2025-02-27
Clearance details
- K-number
- K250021
- Device name
- Rotium
- Applicant
- Nanofiber Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-01-03
- Decision date
- 2025-02-27
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- OWW
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
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| The BioBrace Implant (K203267) | Biorez, Inc. | 2021-04-30 |
| VersaWrap Tendon Protector (K160364) | Alafair Biosciences, Inc. | 2016-06-10 |
| STR GRAFT (K121216) | Soft Tissue Regeneration, Inc. | 2012-11-21 |
Recalls involving this device
No recalls on record reference this clearance.