510(k) K030122

DEPUY SUMMIT BASIC PRESS-FIT HIP STEM by DePuy Orthopaedics, Inc. — Product Code LWJ

K030122 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY SUMMIT BASIC PRESS-FIT HIP STEM". The FDA issued a decision of Substantially Equivalent on February 5, 2003. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2003
Date Received
January 14, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type