OsteoSync™ Ti Dental Mesh

Plate, Bone

Sites Medical, LLC

The following data is part of a premarket notification filed by Sites Medical, Llc with the FDA for Osteosync™ Ti Dental Mesh.

Pre-market Notification Details

Device IDK202918
510k NumberK202918
Device Name:OsteoSync™ Ti Dental Mesh
ClassificationPlate, Bone
Applicant Sites Medical, LLC 5865 E State Road 14 Columbia City,  IN  46725
ContactGreg Stalcup
CorrespondentKaren E Warden
BackRoads Consulting PO BOX 566 Chesterland,  OH  44026
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-07-14

Trademark Results [OsteoSync]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSTEOSYNC
OSTEOSYNC
88952825 not registered Live/Pending
SMED-TA/TD, LLC
2020-06-08
OSTEOSYNC
OSTEOSYNC
87243762 not registered Live/Pending
SMED-TA/TD, LLC
2016-11-21

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