510(k) K990920

DRG TITANIUM BONE PLATE by Doctor'S Research Group, Inc. — Product Code JEY

K990920 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "DRG TITANIUM BONE PLATE". The FDA issued a decision of Substantially Equivalent on June 10, 1999. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1999
Date Received
March 18, 1999
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