FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rotium Bioresorbable Wick
K Number: K183236
·
Decision Mar 11, 2019
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
5
Review Days
111
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Basic Information
- Device Name
- Rotium Bioresorbable Wick
- K Number
- K183236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanofiber Solutions, LLC
- Date Received
- November 20, 2018
- Decision Date
- March 11, 2019
- Product Code
- MAI
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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