TI-6AL-7NB URTN

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Ti-6al-7nb Urtn.

Pre-market Notification Details

Device IDK932330
510k NumberK932330
Device Name:TI-6AL-7NB URTN
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane Cochet-wynant
CorrespondentDiane Cochet-wynant
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-13
Decision Date1996-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679458100 K932330 000
H67947836S0 K932330 000
H67947834S0 K932330 000
H67947833S0 K932330 000
H67947831S0 K932330 000
H67947827S0 K932330 000

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