510(k) K935951

KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM by Kirschner Medical Corp. — Product Code JDI

K935951 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1994. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
December 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type