SUTURE ANCHOR

Staple, Fixation, Bone

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Suture Anchor.

Pre-market Notification Details

Device IDK961578
510k NumberK961578
Device Name:SUTURE ANCHOR
ClassificationStaple, Fixation, Bone
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactJanet G Johnson
CorrespondentJanet G Johnson
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-24
Decision Date1996-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521181625 K961578 000
10884521174610 K961578 000
10884521176881 K961578 000
10884521176898 K961578 000
10884521176874 K961578 000
10884521177031 K961578 000
10884521176904 K961578 000
10884521176935 K961578 000
10884521176942 K961578 000
10884521176966 K961578 000
10884521177024 K961578 000
10884521176959 K961578 000

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