510(k) K140875
K140875 is an FDA 510(k) premarket notification submitted by Genossis, LLC for the device "OPTOSSOL COMPRESSION DEVICE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2014
- Date Received
- April 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type