510(k) K203474

Biomet Microfixation RibFix Advantage System by Biomet Micofixation — Product Code HRS

K203474 is an FDA 510(k) premarket notification submitted by Biomet Micofixation for the device "Biomet Microfixation RibFix Advantage System". The FDA issued a decision of Substantially Equivalent on January 28, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomet Micofixation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2021
Date Received
November 25, 2020
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