510(k) K890498

FREEMAN MODULAR HIP STEM RIDGED VERSION by Orthopedic Systems, Inc. — Product Code JDI

K890498 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "FREEMAN MODULAR HIP STEM RIDGED VERSION". The FDA issued a decision of SN on October 13, 1989. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 13, 1989
Date Received
February 1, 1989
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