GMK-SPHERE Tibial Inserts FLEX Tibial Insert CR And Resurfacing Patella Made Of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)

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 Gmk-sphere Tibial Inserts Flex Tibial Insert Cr And Resurfacing Patella Made Of E-cross (vitamin E Highly Crosslinked Uhmwpe).

Pre-market Notification Details

• Device ID: K202022
• 510k Number: K202022
• Device Name: GMK-SPHERE Tibial Inserts FLEX Tibial Insert CR And Resurfacing Patella Made Of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-22
• Decision Date: 2020-09-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630971262232	K202022	000
07630971262140	K202022	000
07630971262133	K202022	000
07630971262102	K202022	000
07630971262096	K202022	000
07630971262065	K202022	000
07630971262058	K202022	000
07630971262027	K202022	000
07630971262010	K202022	000
07630971261983	K202022	000
07630971261976	K202022	000
07630971261907	K202022	000
07630971261891	K202022	000
07630971261860	K202022	000
07630971261853	K202022	000
07630971261822	K202022	000
07630971261815	K202022	000
07630971262218	K202022	000
07630971262225	K202022	000
07630971262256	K202022	000
07630971262201	K202022	000
07630971262188	K202022	000
07630971262164	K202022	000
07630971262447	K202022	000
07630971262423	K202022	000
07630971262409	K202022	000
07630971262386	K202022	000
07630971262379	K202022	000
07630971262362	K202022	000
07630971262348	K202022	000
07630971262331	K202022	000
07630971262324	K202022	000
07630971262300	K202022	000
07630971262294	K202022	000
07630971262287	K202022	000
07630971262263	K202022	000
07630971261785	K202022	000
07630971261778	K202022	000
07630971261297	K202022	000
07630971261266	K202022	000
07630971261259	K202022	000
07630971261181	K202022	000
07630971261174	K202022	000
07630971261143	K202022	000
07630971261136	K202022	000
07630971261105	K202022	000
07630971261099	K202022	000
07630971261068	K202022	000
07630971261051	K202022	000
07630971261020	K202022	000
07630971261013	K202022	000
07630971261006	K202022	000
07630971260993	K202022	000
07630971260986	K202022	000
07630971261303	K202022	000
07630971261334	K202022	000
07630971261341	K202022	000
07630971261747	K202022	000
07630971261730	K202022	000
07630971261662	K202022	000
07630971261655	K202022	000
07630971261624	K202022	000
07630971261617	K202022	000
07630971261587	K202022	000
07630971261570	K202022	000
07630971261549	K202022	000
07630971261532	K202022	000
07630971261501	K202022	000
07630971261495	K202022	000
07630971261426	K202022	000
07630971261419	K202022	000
07630971261389	K202022	000
07630971261372	K202022	000
07630971260979	K202022	000
07630971261242	K202022	000
07630971261402	K202022	000
07630971261396	K202022	000
07630971261365	K202022	000
07630971261358	K202022	000
07630971261327	K202022	000
07630971261310	K202022	000
07630971261280	K202022	000
07630971261273	K202022	000
07630971262171	K202022	000
07630971262157	K202022	000
07630971262126	K202022	000
07630971262119	K202022	000
07630971262089	K202022	000
07630971262072	K202022	000
07630971262041	K202022	000
07630971262034	K202022	000
07630971261433	K202022	000
07630971261440	K202022	000
07630971261457	K202022	000
07630971261235	K202022	000
07630971261228	K202022	000
07630971261211	K202022	000
07630971261204	K202022	000
07630971261198	K202022	000
07630971261167	K202022	000
07630971261150	K202022	000
07630971261129	K202022	000
07630971261112	K202022	000
07630971261082	K202022	000
07630971261075	K202022	000
07630971261044	K202022	000
07630971261037	K202022	000
07630971261488	K202022	000
07630971261471	K202022	000
07630971261464	K202022	000
07630971262003	K202022	000
07630971261990	K202022	000
07630971261679	K202022	000
07630971261648	K202022	000
07630971261631	K202022	000
07630971261600	K202022	000
07630971261594	K202022	000
07630971261563	K202022	000
07630971261556	K202022	000
07630971261525	K202022	000
07630971261518	K202022	000
07630971262195	K202022	000
07630971262430	K202022	000
07630971262416	K202022	000
07630971262393	K202022	000
07630971262355	K202022	000
07630971262317	K202022	000
07630971262270	K202022	000
07630971261686	K202022	000
07630971261693	K202022	000
07630971261709	K202022	000
07630971261969	K202022	000
07630971261952	K202022	000
07630971261945	K202022	000
07630971261938	K202022	000
07630971261921	K202022	000
07630971261914	K202022	000
07630971261884	K202022	000
07630971261877	K202022	000
07630971261846	K202022	000
07630971261839	K202022	000
07630971261808	K202022	000
07630971261792	K202022	000
07630971261761	K202022	000
07630971261754	K202022	000
07630971261723	K202022	000
07630971261716	K202022	000
07630971262249	K202022	000