BIOSCREW ABSORBABLE INTERFERENCE SREW

Screw, Fixation, Bone

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioscrew Absorbable Interference Srew.

Pre-market Notification Details

Device IDK973758
510k NumberK973758
Device Name:BIOSCREW ABSORBABLE INTERFERENCE SREW
ClassificationScrew, Fixation, Bone
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactCarol A Weideman
CorrespondentCarol A Weideman
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 Received1997-10-02
Decision Date1998-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854014346 K973758 000
20845854013622 K973758 000
20845854013615 K973758 000
20845854013608 K973758 000
30845854013605 K973758 000

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