510(k) K071718

TRILOGY LONGEVITY CONSTRAINED LINER by Zimmer, Inc. — Product Code KWZ

K071718 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "TRILOGY LONGEVITY CONSTRAINED LINER". The FDA issued a decision of Substantially Equivalent on July 13, 2007. 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
July 13, 2007
Date Received
June 22, 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