510(k) K072121

TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER by Zimmer, Inc. — Product Code KWZ

K072121 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER". The FDA issued a decision of Substantially Equivalent on January 7, 2008. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2008
Date Received
August 1, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type