SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

Implant, Endosseous, Orthodontic

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Orthodontic Bone Anchor System.

Pre-market Notification Details

Device IDK063473
510k NumberK063473
Device Name:SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
ClassificationImplant, Endosseous, Orthodontic
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactDeborah L Jackson
CorrespondentDeborah L Jackson
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-16
Decision Date2007-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98004500028050 K063473 000
H980045000080 K063473 000
H980045000100 K063473 000
H980045000120 K063473 000
H980045000130 K063473 000
H980045000140 K063473 000
H980045000150 K063473 000
H980045000160 K063473 000
H980045000170 K063473 000
H98004500024010 K063473 000
H98004500026010 K063473 000
H98004500028010 K063473 000
H98004500034010 K063473 000
H98004500036010 K063473 000
H98004500038010 K063473 000
H98004500024050 K063473 000
H98004500026050 K063473 000
H980045000060 K063473 000

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