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510(k) K202918

OsteoSync™ Ti Dental Mesh by Sites Medical, LLC — Product Code JEY

K202918 is an FDA 510(k) premarket notification submitted by Sites Medical, LLC for the device "OsteoSync™ Ti Dental Mesh". The FDA issued a decision of Substantially Equivalent on July 14, 2021. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2021
Date Received
September 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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FDA data resources