510(k) K896542

ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM)) by Techmedica, Inc. — Product Code JWH

K896542 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))". The FDA issued a decision of Substantially Equivalent on February 15, 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. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
November 17, 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