SYNTHES CURVILINEAR DISTRACTION SYSTEM

External Mandibular Fixator And/or Distractor

SYNTHES INC

The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Curvilinear Distraction System.

Pre-market Notification Details

Device IDK121502
510k NumberK121502
Device Name:SYNTHES CURVILINEAR DISTRACTION SYSTEM
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
ContactAlan T Haley
CorrespondentAlan T Haley
SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-21
Decision Date2012-08-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980045002710 K121502 000
H980045002010 K121502 000
H980045002180 K121502 000
H980045002300 K121502 000
H980045002310 K121502 000
H980045002400 K121502 000
H980045002410 K121502 000
H980045002500 K121502 000
H980045002510 K121502 000
H980045002700 K121502 000
H980045002000 K121502 000

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