510(k) K892503

NUFFIELD TOTAL KNEE by Orthopedic Systems, Inc. — Product Code JWH

K892503 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "NUFFIELD TOTAL KNEE". The FDA issued a decision of SN on May 4, 1990. 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. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 4, 1990
Date Received
April 11, 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