FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rotium
K Number: K250021
·
Decision Feb 27, 2025
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
9
Applicant Total
5
Review Days
55
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Basic Information
- Device Name
- Rotium
- K Number
- K250021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanofiber Solutions, LLC
- Date Received
- January 3, 2025
- Decision Date
- February 27, 2025
- Product Code
- OWW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
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