510(k) K173910
K173910 is an FDA 510(k) premarket notification submitted by Cable Fix Medical, LLC for the device "Impress SFS System". The FDA issued a decision of Substantially Equivalent on September 14, 2018. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2018
- Date Received
- December 22, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type