HARPOON SUTURE ANCHORS

Fastener, Fixation, Nondegradable, Soft Tissue

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Harpoon Suture Anchors.

Pre-market Notification Details

Device IDK973775
510k NumberK973775
Device Name:HARPOON SUTURE ANCHORS
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactMary Verstynen
CorrespondentMary Verstynen
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-03
Decision Date1998-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304465541 K973775 000
00880304464810 K973775 000
00880304430952 K973775 000
00880304430945 K973775 000

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