510(k) K920080

CONTINUUM KNEE SYSTEM by Techmedica, Inc. — Product Code JWH

K920080 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "CONTINUUM KNEE SYSTEM". The FDA issued a decision of SN on September 1, 1992. 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
SN ()
Decision Date
September 1, 1992
Date Received
January 8, 1992
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