COMPOSITE HITCH SUTURE ANCHOR

Staple, Fixation, Bone

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Composite Hitch Suture Anchor.

Pre-market Notification Details

Device IDK081172
510k NumberK081172
Device Name:COMPOSITE HITCH SUTURE ANCHOR
ClassificationStaple, Fixation, Bone
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-24
Decision Date2008-07-17
Summary:summary

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