ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

ASCENSION ORTHOPEDICS, INC.

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

Pre-market Notification Details

• Device ID: K062861
• 510k Number: K062861
• Device Name: ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
• Classification: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
• Applicant: ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832
• Contact: Glen Neally
• Correspondent: Glen Neally; ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832
• Product Code: HSD
• CFR Regulation Number: 888.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-25
• Decision Date: 2006-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556837320	K062861	000
00885556837528	K062861	000
00885556837535	K062861	000
00885556837207	K062861	000
00885556837214	K062861	000
00885556837221	K062861	000
00885556837238	K062861	000
00885556837245	K062861	000
00885556837252	K062861	000
00885556837269	K062861	000
00885556837511	K062861	000
00885556837504	K062861	000
00885556837337	K062861	000
00885556837344	K062861	000
00885556837351	K062861	000
00885556837368	K062861	000
00885556837375	K062861	000
00885556837467	K062861	000
00885556837474	K062861	000
00885556837481	K062861	000
00885556837498	K062861	000
00885556837276	K062861	000
M268HRARTHIMP1	K062861	000
10381780116172	K062861	000
M269TRL90048201	K062861	000
M269TRL90052181	K062861	000
M269TRL90052211	K062861	000
M269TRL90056211	K062861	000
M269SHP90044181	K062861	000
M269SHP90048171	K062861	000
M269SHP90048201	K062861	000
M269SHP90052181	K062861	000
M269SHP90052211	K062861	000
M269TRL90048171	K062861	000
M269TRL90044181	K062861	000
10381780116165	K062861	000
10381780116189	K062861	000
10381780116196	K062861	000
10381780116202	K062861	000
M269HRA9005218WW1	K062861	000
10381780116226	K062861	000
10381780116233	K062861	000
M269TRL90040161	K062861	000
M269TRL90044151	K062861	000
M269SHP90056211	K062861	000