SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) External Fixation Component Line Extension - Mr Safe.

Pre-market Notification Details

Device IDK043039
510k NumberK043039
Device Name:SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactKathy Anderson
CorrespondentKathy Anderson
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-04
Decision Date2005-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6793956930 K043039 000
H6793900270 K043039 000
H6793900280 K043039 000
H6793947910 K043039 000
H6793947920 K043039 000
H6793947930 K043039 000
H6793956900 K043039 000
H6793956910 K043039 000
H6793900090 K043039 000
H6793900100 K043039 000
H6793900120 K043039 000
H6793900130 K043039 000
H6793900260 K043039 000
H6793900290 K043039 000
H6793900300 K043039 000
H6793956920 K043039 000
H6793900110 K043039 000

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