510(k) K143365
K143365 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "Eminent Foot Plate System". The FDA issued a decision of Substantially Equivalent on March 30, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Eminent Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2015
- Date Received
- November 24, 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