BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE

Screw, Fixation, Bone

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioanchor With Disposable Driver, Preloaded With One #2 Herculine Suture.

Pre-market Notification Details

Device IDK042778
510k NumberK042778
Device Name:BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
ClassificationScrew, Fixation, Bone
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactElizabeth Paul
CorrespondentElizabeth Paul
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-06
Decision Date2004-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854030797 K042778 000

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