PRE-LOADED BIOSTINGER HORNET

Screw, Fixation, Bone

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Pre-loaded Biostinger Hornet.

Pre-market Notification Details

Device IDK020377
510k NumberK020377
Device Name:PRE-LOADED BIOSTINGER HORNET
ClassificationScrew, Fixation, Bone
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Seneff
CorrespondentLaura D Seneff
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-05
Decision Date2002-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854014469 K020377 000
20845854014421 K020377 000
20845854013486 K020377 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.