510(k) K170418
K170418 is an FDA 510(k) premarket notification submitted by Stryker Trauma GmbH for the device "Stryker SonicPin System". The FDA issued a decision of Substantially Equivalent on Jun 20, 2017. 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
- Jun 20, 2017
- Date Received
- Feb 13, 2017
- 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)