A.L.P.S. Clavicle Plating System

Plate, Fixation, Bone

Biomet Inc.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for A.l.p.s. Clavicle Plating System.

Pre-market Notification Details

Device IDK210192
510k NumberK210192
Device Name:A.L.P.S. Clavicle Plating System
ClassificationPlate, Fixation, Bone
Applicant Biomet Inc. 56 East Bell Drive Warsaw,  IN  46581
ContactKyle Ponce
CorrespondentKyle Ponce
Biomet Inc. 56 East Bell Drive Warsaw,  IN  46581
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-02-19

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