510(k) K936274

KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM by Kirschner Medical Corp. — Product Code JWH

K936274 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 18, 1995. 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. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1995
Date Received
December 30, 1993
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