HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712

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

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Highly Cross-linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712.

Pre-market Notification Details

• Device ID: K091956
• 510k Number: K091956
• Device Name: HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Contact: Elizabeth Onderlinde
• Correspondent: Elizabeth Onderlinde; ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Product Code: OIY
• Subsequent Product Code: JWH
• Subsequent Product Code: MBH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-01
• Decision Date: 2010-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888912120036	K091956	000
00888912119764	K091956	000
00888912119757	K091956	000
00888912119740	K091956	000
00888912119733	K091956	000
00888912119726	K091956	000
00888912119719	K091956	000
00888912119542	K091956	000
00888912119535	K091956	000
00888912119528	K091956	000
00888912119771	K091956	000
00888912119788	K091956	000
00888912120029	K091956	000
00888912120012	K091956	000
00888912120005	K091956	000
00888912119993	K091956	000
00888912119986	K091956	000
00888912119979	K091956	000
00888912119962	K091956	000
00888912119955	K091956	000
00888912119795	K091956	000
00888912119511	K091956	000
00888912119504	K091956	000
00888912119498	K091956	000
00888912119184	K091956	000
00888912119009	K091956	000
00888912118996	K091956	000
00888912118989	K091956	000
00888912118972	K091956	000
00888912118965	K091956	000
00888912118958	K091956	000
00888912118941	K091956	000
00888912118934	K091956	000
00888912119191	K091956	000
00888912119207	K091956	000
00888912119481	K091956	000
00888912119474	K091956	000
00888912119467	K091956	000
00888912119276	K091956	000
00888912119269	K091956	000
00888912119252	K091956	000
00888912119245	K091956	000
00888912119221	K091956	000
00888912119214	K091956	000
00888912118927	K091956	000
00888912121309	K091956	000
00888912121033	K091956	000
00888912121026	K091956	000
00888912121019	K091956	000
00888912121002	K091956	000
00888912120999	K091956	000
00888912120982	K091956	000
00888912120814	K091956	000
00888912120807	K091956	000
00888912120791	K091956	000
00888912121040	K091956	000
00888912121057	K091956	000
00888912121293	K091956	000
00888912121286	K091956	000
00888912121279	K091956	000
00888912121262	K091956	000
00888912121255	K091956	000
00888912121248	K091956	000
00888912121231	K091956	000
00888912121224	K091956	000
00888912121064	K091956	000
00888912120784	K091956	000
00888912120777	K091956	000
00888912120760	K091956	000
00888912120494	K091956	000
00888912120302	K091956	000
00888912120296	K091956	000
00888912120289	K091956	000
00888912120272	K091956	000
00888912120265	K091956	000
00888912120258	K091956	000
00888912120241	K091956	000
00888912120234	K091956	000
00888912120500	K091956	000
00888912120517	K091956	000
00888912120753	K091956	000
00888912120746	K091956	000
00888912120739	K091956	000
00888912120579	K091956	000
00888912120562	K091956	000
00888912120555	K091956	000
00888912120548	K091956	000
00888912120531	K091956	000
00888912120524	K091956	000
00888912120227	K091956	000