510(k) K222574
K222574 is an FDA 510(k) premarket notification submitted by Simparo, Inc. for the device "Simparo Anchor Line Fixation System". The FDA issued a decision of Substantially Equivalent on Feb 4, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 4, 2023
- Date Received
- Aug 25, 2022
- 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
- 510(k)