510(k) K233730
K233730 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "Footprint Mini PK, 3.5mm Suture Anchor". The FDA issued a decision of Substantially Equivalent on January 17, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2024
- Date Received
- November 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type