510(k) K900619

CAAS UNICOMPARMENTAL KNEE SYSTEM by Techmedica, Inc. — Product Code HSX

K900619 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "CAAS UNICOMPARMENTAL KNEE SYSTEM". The FDA issued a decision of SN on June 11, 1990. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 11, 1990
Date Received
February 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type