510(k) K103001

ROCKWOOD CLAVICLE PINS by DePuy Orthopaedics, Inc. — Product Code JDW

K103001 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "ROCKWOOD CLAVICLE PINS". The FDA issued a decision of Substantially Equivalent on February 17, 2011. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2011
Date Received
October 6, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type