510(k) K151173

Biomet Microfixation RibFix Blu Thoracic Fixation System by Biomet Microfixation — Product Code HWC

K151173 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Biomet Microfixation RibFix Blu Thoracic Fixation System". The FDA issued a decision of Substantially Equivalent on May 26, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Biomet Microfixation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2015
Date Received
May 1, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type