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 IDK093299
510k NumberK093299
Device Name:SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
ClassificationImplant, Endosseous, Orthodontic
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactAlan T Haley
CorrespondentAlan T Haley
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 Received2009-10-21
Decision Date2010-12-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.