U2 Total Knee System, PSA Tibial Insert

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

UNITED ORTHOPEDIC CORPORATION

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U2 Total Knee System, Psa Tibial Insert.

Pre-market Notification Details

• Device ID: K161360
• 510k Number: K161360
• Device Name: U2 Total Knee System, PSA Tibial Insert
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Karen Ho
• Correspondent: Karen Ho; UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-16
• Decision Date: 2017-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719872148883	K161360	000
04719872148753	K161360	000
04719872148746	K161360	000
04719872148739	K161360	000
04719872148722	K161360	000
04719872148715	K161360	000
04719872148708	K161360	000
04719872148692	K161360	000
04719872148685	K161360	000
04719872148678	K161360	000
04719872148661	K161360	000
04719872148760	K161360	000
04719872148777	K161360	000
04719872148876	K161360	000
04719872148869	K161360	000
04719872148852	K161360	000
04719872148845	K161360	000
04719872148838	K161360	000
04719872148821	K161360	000
04719872148814	K161360	000
04719872148807	K161360	000
04719872148791	K161360	000
04719872148784	K161360	000
04719872148654	K161360	000
04719872148647	K161360	000
04719872148517	K161360	000
04719872148500	K161360	000
04719872148494	K161360	000
04719872148487	K161360	000
04719872148470	K161360	000
04719872148463	K161360	000
04719872148456	K161360	000
04719872148449	K161360	000
04719872148432	K161360	000
04719872148425	K161360	000
04719872148524	K161360	000
04719872148531	K161360	000
04719872148630	K161360	000
04719872148623	K161360	000
04719872148616	K161360	000
04719872148609	K161360	000
04719872148593	K161360	000
04719872148586	K161360	000
04719872148579	K161360	000
04719872148562	K161360	000
04719872148555	K161360	000
04719872148548	K161360	000
04719872148418	K161360	000
04719872149842	K161360	000
04719872149712	K161360	000
04719872149705	K161360	000
04719872149699	K161360	000
04719872149682	K161360	000
04719872149675	K161360	000
04719872149668	K161360	000
04719872149651	K161360	000
04719872149644	K161360	000
04719872149637	K161360	000
04719872149620	K161360	000
04719872149729	K161360	000
04719872149736	K161360	000
04719872149835	K161360	000
04719872149828	K161360	000
04719872149811	K161360	000
04719872149804	K161360	000
04719872149798	K161360	000
04719872149781	K161360	000
04719872149774	K161360	000
04719872149767	K161360	000
04719872149750	K161360	000
04719872149743	K161360	000
04719872149613	K161360	000
04719872149606	K161360	000
04719872149477	K161360	000
04719872149460	K161360	000
04719872149453	K161360	000
04719872149446	K161360	000
04719872149439	K161360	000
04719872149422	K161360	000
04719872149415	K161360	000
04719872149408	K161360	000
04719872149392	K161360	000
04719872149385	K161360	000
04719872149484	K161360	000
04719872149491	K161360	000
04719872149590	K161360	000
04719872149583	K161360	000
04719872149576	K161360	000
04719872149569	K161360	000
04719872149552	K161360	000
04719872149545	K161360	000
04719872149538	K161360	000
04719872149521	K161360	000
04719872149514	K161360	000
04719872149507	K161360	000
04719872149378	K161360	000