510(k) K982670

CONTEMPORARY ACETABULAR COMPONENT by Howmedica Corp. — Product Code JDI

K982670 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "CONTEMPORARY ACETABULAR COMPONENT". The FDA issued a decision of Substantially Equivalent on October 2, 1998. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1998
Date Received
July 31, 1998
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