510(k) K143138
K143138 is an FDA 510(k) premarket notification submitted by Stryker Trauma AG for the device "AxSOS 3 Ti Locking Plate System". The FDA issued a decision of Substantially Equivalent on Dec 22, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker Trauma AG has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2014
- Date Received
- Nov 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)