510(k) K143063
K143063 is an FDA 510(k) premarket notification submitted by Stryker Trauma GmbH for the device "Stryker SonicPin System, Stryker SonicAnchor System". The FDA issued a decision of Substantially Equivalent on Jan 27, 2015. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Stryker Trauma GmbH has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 27, 2015
- Date Received
- Oct 24, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)