TITAN REVERSE SHOULDER SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

ASCENSION ORTHOPEDIC

The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Titan Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K130050
• 510k Number: K130050
• Device Name: TITAN REVERSE SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754
• Contact: Susan Walton
• Correspondent: Susan Walton; ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-09
• Decision Date: 2013-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M268TSSREVIMP1	K130050	000
00885556864623	K130050	000
00885556864579	K130050	000
00885556864562	K130050	000
00885556864555	K130050	000
00885556864548	K130050	000
00885556864531	K130050	000
00885556864524	K130050	000
00885556864517	K130050	000
00885556864500	K130050	000
00885556864630	K130050	000
00885556864647	K130050	000
00885556864654	K130050	000
00885556864777	K130050	000
00885556864760	K130050	000
00885556864722	K130050	000
00885556864715	K130050	000
00885556864708	K130050	000
00885556864692	K130050	000
00885556864685	K130050	000
00885556864678	K130050	000
00885556864661	K130050	000
00885556864494	K130050	000
00885556864395	K130050	000
00885556864029	K130050	000
00885556863787	K130050	000
00885556863770	K130050	000
00885556863763	K130050	000
00885556863756	K130050	000
00885556863749	K130050	000
00885556863732	K130050	000
00885556863480	K130050	000
00885556863473	K130050	000
00885556864036	K130050	000
00885556864043	K130050	000
00885556864050	K130050	000
00885556864388	K130050	000
00885556864371	K130050	000
00885556864364	K130050	000
00885556864357	K130050	000
00885556864340	K130050	000
00885556864098	K130050	000
00885556864081	K130050	000
00885556864074	K130050	000
00885556864067	K130050	000
00885556863466	K130050	000
00885556863725	K130050	000
10381780441120	K130050	000
M269TRL096000R1	K130050	000
10381780121831	K130050	000
10381780121824	K130050	000
10381780121817	K130050	000
10381780121800	K130050	000
10381780121794	K130050	000
10381780121787	K130050	000
10381780121770	K130050	000
10381780121763	K130050	000
M269TRL096000S1	K130050	000
M269TRL096002C1	K130050	000
M269TRL096002E1	K130050	000
M269TRL096009S1	K130050	000
M269TRL096009R1	K130050	000
M269TRL096006S1	K130050	000
M269TRL096006R1	K130050	000
M269TRL096005E1	K130050	000
M269TRL096005C1	K130050	000
M269TRL096003S1	K130050	000
M269TRL096003R1	K130050	000
M269TRL096002EL1	K130050	000
10381780121756	K130050	000
10381780121749	K130050	000
10381780121619	K130050	000
M269LNR096003S1	K130050	000
M269LNR096000S1	K130050	000
10381780121589	K130050	000
10381780121572	K130050	000
M269LNR096003R1	K130050	000
M269LNR096000R1	K130050	000
M269BBS096021LRG1	K130050	000
M269BBS096021STD1	K130050	000
10381780121626	K130050	000
M269GLS096002C1	K130050	000
M269GLS096005C1	K130050	000
10381780121732	K130050	000
10381780121725	K130050	000
10381780121718	K130050	000
10381780121701	K130050	000
10381780121695	K130050	000
10381780121688	K130050	000
10381780121671	K130050	000
M269GLS096005E1	K130050	000
M269GLS096002E1	K130050	000
10381780121527	K130050	000