MODIFICATION TO: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 Modification To:synthes (usa) Titanium Wire.

Pre-market Notification Details

Device IDK042606
510k NumberK042606
Device Name:MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
ClassificationSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactKathy Anderson
CorrespondentKathy Anderson
SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeGAQ  
CFR Regulation Number878.4495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-24
Decision Date2005-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887587056210 K042606 000
H98049310401S0 K042606 000

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