510(k) K013786

DRG ORTHOHEX SS BONE SCREW by Doctor'S Research Group, Inc. — Product Code HWC

K013786 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "DRG ORTHOHEX SS BONE SCREW". The FDA issued a decision of Substantially Equivalent on December 17, 2001. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2001
Date Received
November 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type