ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

BIODYNAMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Anatomic Proportional Shoulder Aps (hemi-shoulder) System.

Pre-market Notification Details

• Device ID: K935593
• 510k Number: K935593
• Device Name: ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
• Classification: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
• Applicant: BIODYNAMIC TECHNOLOGIES, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520
• Contact: David W Schlerf
• Correspondent: David W Schlerf; BIODYNAMIC TECHNOLOGIES, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520
• Product Code: HSD
• CFR Regulation Number: 888.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-19
• Decision Date: 1994-10-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327138160	K935593	000
07613327137910	K935593	000
07613327137903	K935593	000
07613327137880	K935593	000
07613327137873	K935593	000
07613327137866	K935593	000
07613327137859	K935593	000
07613327137842	K935593	000
07613327137828	K935593	000
07613327137811	K935593	000
07613327137804	K935593	000
07613327137798	K935593	000
07613327137781	K935593	000
07613327137750	K935593	000
07613327137743	K935593	000
07613327137927	K935593	000
07613327137934	K935593	000
07613327137941	K935593	000
07613327138115	K935593	000
07613327138092	K935593	000
07613327138078	K935593	000
07613327138061	K935593	000
07613327138054	K935593	000
07613327138030	K935593	000
07613327138023	K935593	000
07613327138016	K935593	000
07613327138009	K935593	000
07613327137996	K935593	000
07613327137989	K935593	000
07613327137972	K935593	000
07613327137965	K935593	000
07613327137958	K935593	000
07613327137736	K935593	000