SnapShot Fixation System

Staple, Fixation, Bone

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Snapshot Fixation System.

Pre-market Notification Details

Device IDK143037
510k NumberK143037
Device Name:SnapShot Fixation System
ClassificationStaple, Fixation, Bone
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactAdam Cargill
CorrespondentAdam Cargill
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-22
Decision Date2015-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304685512 K143037 000
00880304685475 K143037 000
00887868251061 K143037 000
00887868251054 K143037 000

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