510(k) K890132

POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. by Richards Medical Co., Inc. — Product Code JWH

K890132 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.". The FDA issued a decision of SN on July 19, 1989. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 19, 1989
Date Received
January 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type