510(k) K142823

Biomet Microfixation Thoracic Fixation System by Biomet Microfixation — Product Code HRS

K142823 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Biomet Microfixation Thoracic Fixation System". The FDA issued a decision of Substantially Equivalent on February 25, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomet Microfixation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2015
Date Received
September 30, 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