510(k) K083107

MODIFICATION TO DEPUY NEUFLEX PIP FINGER by DePuy Orthopaedics, Inc. — Product Code KYJ

K083107 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "MODIFICATION TO DEPUY NEUFLEX PIP FINGER". The FDA issued a decision of Substantially Equivalent on February 9, 2009. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2009
Date Received
October 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Finger, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3230
Review Panel
OR
Submission Type