EVOLIS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

MEDACTA INTERNATIONAL, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Evolis Total Knee System.

Pre-market Notification Details

• Device ID: K081023
• 510k Number: K081023
• Device Name: EVOLIS TOTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Contact: Natalie J Kennel
• Correspondent: Natalie J Kennel; MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-10
• Decision Date: 2008-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030845475	K081023	000
07630030845260	K081023	000
07630030845253	K081023	000
07630030845246	K081023	000
07630030845239	K081023	000
07630030845222	K081023	000
07630030845215	K081023	000
07630030845208	K081023	000
07630030845192	K081023	000
07630030845185	K081023	000
07630030845055	K081023	000
07630030845048	K081023	000
07630030845031	K081023	000
07630030845024	K081023	000
07630030845017	K081023	000
07630030845000	K081023	000
07630030844997	K081023	000
07630030844980	K081023	000
07630030845277	K081023	000
07630030845284	K081023	000
07630030845291	K081023	000
07630030845468	K081023	000
07630030845451	K081023	000
07630030845444	K081023	000
07630030845437	K081023	000
07630030845420	K081023	000
07630030845413	K081023	000
07630030845406	K081023	000
07630030845390	K081023	000
07630030845383	K081023	000
07630030845376	K081023	000
07630030845369	K081023	000
07630030845352	K081023	000
07630030845345	K081023	000
07630030845338	K081023	000
07630030845321	K081023	000
07630030845314	K081023	000
07630030845307	K081023	000
07630030844973	K081023	000
07630030844966	K081023	000
07630030844638	K081023	000
07630030844621	K081023	000
07630030844614	K081023	000
07630030844607	K081023	000
07630030844591	K081023	000
07630030844584	K081023	000
07630030844577	K081023	000
07630030844560	K081023	000
07630030844553	K081023	000
07630030844546	K081023	000
07630030844539	K081023	000
07630030844522	K081023	000
07630030844515	K081023	000
07630030844508	K081023	000
07630030844492	K081023	000
07630030844485	K081023	000
07630030844478	K081023	000
07630030844645	K081023	000
07630030844652	K081023	000
07630030844669	K081023	000
07630030844959	K081023	000
07630030844942	K081023	000
07630030844935	K081023	000
07630030844928	K081023	000
07630030844911	K081023	000
07630030844904	K081023	000
07630030844898	K081023	000
07630030844881	K081023	000
07630030844874	K081023	000
07630030844867	K081023	000
07630030844850	K081023	000
07630030844843	K081023	000
07630030844836	K081023	000
07630030844829	K081023	000
07630030844690	K081023	000
07630030844683	K081023	000
07630030844676	K081023	000
07630030844461	K081023	000
07630030845482	K081023	000
07630030846564	K081023	000
07630030846359	K081023	000
07630030846342	K081023	000
07630030846335	K081023	000
07630030846328	K081023	000
07630030846311	K081023	000
07630030846304	K081023	000
07630030846298	K081023	000
07630030846281	K081023	000
07630030846274	K081023	000
07630030846267	K081023	000
07630030846250	K081023	000
07630030846243	K081023	000
07630030846236	K081023	000
07630030846229	K081023	000
07630030846212	K081023	000
07630030846205	K081023	000
07630030845895	K081023	000
07630030846366	K081023	000
07630030846373	K081023	000
07630030846380	K081023	000
07630030846557	K081023	000
07630030846540	K081023	000
07630030846533	K081023	000
07630030846526	K081023	000
07630030846519	K081023	000
07630030846502	K081023	000
07630030846496	K081023	000
07630030846489	K081023	000
07630030846472	K081023	000
07630030846465	K081023	000
07630030846458	K081023	000
07630030846441	K081023	000
07630030846434	K081023	000
07630030846427	K081023	000
07630030846410	K081023	000
07630030846403	K081023	000
07630030846397	K081023	000
07630030845888	K081023	000
07630030845871	K081023	000
07630030845666	K081023	000
07630030845659	K081023	000
07630030845642	K081023	000
07630030845635	K081023	000
07630030845628	K081023	000
07630030845611	K081023	000
07630030845604	K081023	000
07630030845598	K081023	000
07630030845581	K081023	000
07630030845574	K081023	000
07630030845567	K081023	000
07630030845550	K081023	000
07630030845543	K081023	000
07630030845536	K081023	000
07630030845529	K081023	000
07630030845512	K081023	000
07630030845505	K081023	000
07630030845673	K081023	000
07630030845680	K081023	000
07630030845697	K081023	000
07630030845864	K081023	000
07630030845857	K081023	000
07630030845840	K081023	000
07630030845833	K081023	000
07630030845826	K081023	000
07630030845819	K081023	000
07630030845802	K081023	000
07630030845796	K081023	000
07630030845789	K081023	000
07630030845772	K081023	000
07630030845765	K081023	000
07630030845758	K081023	000
07630030845741	K081023	000
07630030845734	K081023	000
07630030845727	K081023	000
07630030845710	K081023	000
07630030845703	K081023	000
07630030845499	K081023	000