510(k) K141493
K141493 is an FDA 510(k) premarket notification submitted by Miami Device Solutions for the device "PROXIMAL HUMERUS PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Miami Device Solutions has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2015
- Date Received
- June 5, 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