FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRORAPTOR REGENESORB Suture Anchor
K Number: K180361
·
Decision May 30, 2018
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
7
Review Days
110
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Basic Information
- Device Name
- MICRORAPTOR REGENESORB Suture Anchor
- K Number
- K180361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith and Nephew, Inc.
- Date Received
- February 9, 2018
- Decision Date
- May 30, 2018
- 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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