OTI ORTHOPEDIC WIRE SYSTEM

Cerclage, Fixation

OSTEO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Oti Orthopedic Wire System.

Pre-market Notification Details

Device IDK925447
510k NumberK925447
Device Name:OTI ORTHOPEDIC WIRE SYSTEM
ClassificationCerclage, Fixation
Applicant OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-28
Decision Date1993-06-29

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