INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

Plate, Fixation, Bone

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Integra Proximal Humeral Plate System.

Pre-market Notification Details

• Device ID: K121826
• 510k Number: K121826
• Device Name: INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD Austin, TX 78754
• Contact: Susan Walton
• Correspondent: Susan Walton; ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD Austin, TX 78754
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-21
• Decision Date: 2013-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556830406	K121826	000
00885556830253	K121826	000
00885556830246	K121826	000
00885556830239	K121826	000
00885556830222	K121826	000
00885556830215	K121826	000
00885556830208	K121826	000
00885556830192	K121826	000
00885556830185	K121826	000
00885556830178	K121826	000
00885556830161	K121826	000
00885556830154	K121826	000
00885556830147	K121826	000
00885556830260	K121826	000
00885556830277	K121826	000
00885556830390	K121826	000
00885556830383	K121826	000
00885556830376	K121826	000
00885556830369	K121826	000
00885556830352	K121826	000
00885556830345	K121826	000
00885556830338	K121826	000
00885556830321	K121826	000
00885556830314	K121826	000
00885556830307	K121826	000
00885556830291	K121826	000
00885556830284	K121826	000
00885556830130	K121826	000
00885556830123	K121826	000
00885556829974	K121826	000
00885556829875	K121826	000
00885556829868	K121826	000
00885556829851	K121826	000
00885556829844	K121826	000
00885556829837	K121826	000
00885556829820	K121826	000
00885556829813	K121826	000
00885556829806	K121826	000
00885556829790	K121826	000
00885556829783	K121826	000
00885556829776	K121826	000
00885556829981	K121826	000
00885556829998	K121826	000
00885556830116	K121826	000
00885556830109	K121826	000
00885556830093	K121826	000
00885556830086	K121826	000
00885556830079	K121826	000
00885556830062	K121826	000
00885556830055	K121826	000
00885556830048	K121826	000
00885556830031	K121826	000
00885556830024	K121826	000
00885556830017	K121826	000
00885556830000	K121826	000
00885556829769	K121826	000
M269HFP0930109LS1	K121826	000
M269PSS3560PS1	K121826	000
M269PSS3555PS1	K121826	000
10381780121282	K121826	000
M269PSS3545PS1	K121826	000
M269PSS3540PS1	K121826	000
10381780121251	K121826	000
M269PSS3570LS1	K121826	000
M269PSS3565LS1	K121826	000
M269PSS3560LS1	K121826	000
M269PSS3555LS1	K121826	000
M269PSS3550LS1	K121826	000
M269PSS3545LS1	K121826	000
M269PSS3565PS1	K121826	000
M269PSS3570PS1	K121826	000
M269HFP0930109RS1	K121826	000
10381780120872	K121826	000
10381780120865	K121826	000
10381780120858	K121826	000
10381780120841	K121826	000
10381780120834	K121826	000
10381780120827	K121826	000
10381780120810	K121826	000
10381780120803	K121826	000
10381780120797	K121826	000
10381780120780	K121826	000
M269PSS3575PS1	K121826	000
M269PSS3540LS1	K121826	000
M269PSS3537LS1	K121826	000
M269PSS3527CS1	K121826	000
M269PSS3525CS1	K121826	000
M269PSS3522CS1	K121826	000
M269PSS3517CS1	K121826	000
M269PSS3515CS1	K121826	000
M269PSS2725LS1	K121826	000
M269PSS2722LS1	K121826	000
M269PSS2720LS1	K121826	000
M269PSS2717LS1	K121826	000
M269PSS2715LS1	K121826	000
M269PSS2712LS1	K121826	000
10381780120902	K121826	000
10381780121039	K121826	000
M269PSS3532CS1	K121826	000
M269PSS3535LS1	K121826	000
M269PSS3532LS1	K121826	000
M269PSS3530LS1	K121826	000
M269PSS3527LS1	K121826	000
M269PSS3525LS1	K121826	000
M269PSS3522LS1	K121826	000
M269PSS3520LS1	K121826	000
M269PSS3517LS1	K121826	000
M269PSS3515LS1	K121826	000
M269PSS3540CS1	K121826	000
M269PSS3537CS1	K121826	000
10381780121053	K121826	000
M268HFPLATEIMP1	K121826	000