510(k) K173775
K173775 is an FDA 510(k) premarket notification submitted by F & A Foundation, LLC D.B.A. Reign Medical for the device "Clench Compression Staple". The FDA issued a decision of Substantially Equivalent on Apr 6, 2018. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 6, 2018
- Date Received
- Dec 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)