SYNTHES (USA) TITANIUM WIRE

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Titanium Wire.

Pre-market Notification Details

Device IDK041333
510k NumberK041333
Device Name:SYNTHES (USA) TITANIUM WIRE
ClassificationSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeGAQ  
CFR Regulation Number878.4495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-19
Decision Date2004-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98049310301S0 K041333 000
H98049310201S0 K041333 000
H98049310101S0 K041333 000
10887587056166 K041333 000

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