510(k) K961799

NATURAL HIP SYSTEM - DRG HIP STEM by Intermedics Orthopedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1996
Date Received
May 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type