FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Footprint Mini PK, 3.5mm Suture Anchor
K Number: K233730
·
Decision Jan 17, 2024
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
14
Review Days
57
Basic Information
- Device Name
- Footprint Mini PK, 3.5mm Suture Anchor
- K Number
- K233730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew
- Date Received
- November 21, 2023
- Decision Date
- January 17, 2024
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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