LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Longevity It Highly Crosslinked Polyethylene Constrained Liners.

Pre-market Notification Details

• Device ID: K101730
• 510k Number: K101730
• Device Name: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
• Classification: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Bradley Strasser
• Correspondent: Bradley Strasser; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: KWZ
• CFR Regulation Number: 888.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-18
• Decision Date: 2010-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024148956	K101730	000
00889024148833	K101730	000
00889024148826	K101730	000
00889024148819	K101730	000
00889024148802	K101730	000
00889024148796	K101730	000
00889024148789	K101730	000
00889024154889	K101730	000
00889024154872	K101730	000
00889024154865	K101730	000
00889024148840	K101730	000
00889024148857	K101730	000
00889024148949	K101730	000
00889024148932	K101730	000
00889024148925	K101730	000
00889024148918	K101730	000
00889024148901	K101730	000
00889024148895	K101730	000
00889024148888	K101730	000
00889024148871	K101730	000
00889024148864	K101730	000
00889024154858	K101730	000
00889024154841	K101730	000
00889024154834	K101730	000
00889024154711	K101730	000
00889024154704	K101730	000
00889024154698	K101730	000
00889024154681	K101730	000
00889024154674	K101730	000
00889024154667	K101730	000
00889024154650	K101730	000
00889024154643	K101730	000
00889024154636	K101730	000
00889024154728	K101730	000
00889024154735	K101730	000
00889024154827	K101730	000
00889024154810	K101730	000
00889024154803	K101730	000
00889024154797	K101730	000
00889024154780	K101730	000
00889024154773	K101730	000
00889024154766	K101730	000
00889024154759	K101730	000
00889024154742	K101730	000
00889024154629	K101730	000
00889024152373	K101730	000
00889024152045	K101730	000
00889024152038	K101730	000
00889024152021	K101730	000
00889024152014	K101730	000
00889024152007	K101730	000
00889024151994	K101730	000
00889024151987	K101730	000
00889024151970	K101730	000
00889024151963	K101730	000
00889024152052	K101730	000
00889024152069	K101730	000
00889024152366	K101730	000
00889024152359	K101730	000
00889024152281	K101730	000
00889024152274	K101730	000
00889024152267	K101730	000
00889024152250	K101730	000
00889024152243	K101730	000
00889024152236	K101730	000
00889024152076	K101730	000
00889024151956	K101730	000
00889024151949	K101730	000
00889024151932	K101730	000
00889024151819	K101730	000
00889024149045	K101730	000
00889024149038	K101730	000
00889024149021	K101730	000
00889024149014	K101730	000
00889024149007	K101730	000
00889024148994	K101730	000
00889024148987	K101730	000
00889024148970	K101730	000
00889024151826	K101730	000
00889024151833	K101730	000
00889024151925	K101730	000
00889024151918	K101730	000
00889024151901	K101730	000
00889024151895	K101730	000
00889024151888	K101730	000
00889024151871	K101730	000
00889024151864	K101730	000
00889024151857	K101730	000
00889024151840	K101730	000
00889024148963	K101730	000