SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

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 Distraction Osteogenesis System, Mr Conditional With Expanded Indications.

Pre-market Notification Details

Device IDK092190
510k NumberK092190
Device Name:SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactJill R Yelton
CorrespondentJill R Yelton
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-21
Decision Date2010-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679033112150 K092190 000
H679033110460 K092190 000
H679033110380 K092190 000
H679033110370 K092190 000
H679033110250 K092190 000
H679033110240 K092190 000
H679033110230 K092190 000
H679033110220 K092190 000
H679033110200 K092190 000
H679033110470 K092190 000
H679033110480 K092190 000
H679033110540 K092190 000
H679033112140 K092190 000
H679033112130 K092190 000
H679033112120 K092190 000
H679033111750 K092190 000
H679033111740 K092190 000
H679033111730 K092190 000
H679033111720 K092190 000
H679033111710 K092190 000
H679033110150 K092190 000

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