MINI VARIABLE SYSTEM

Plate, Fixation, Bone

ORTHOHELIX SURGICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Mini Variable System.

Pre-market Notification Details

• Device ID: K111041
• 510k Number: K111041
• Device Name: MINI VARIABLE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256
• Contact: Derek Lewis
• Correspondent: Derek Lewis; ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-14
• Decision Date: 2011-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846832057146	K111041	000
00846832056958	K111041	000
00846832056941	K111041	000
00846832056934	K111041	000
00846832056927	K111041	000
00846832056910	K111041	000
00846832056903	K111041	000
00846832056897	K111041	000
00846832056880	K111041	000
00846832056873	K111041	000
00846832056866	K111041	000
00846832056859	K111041	000
00846832056842	K111041	000
00846832056835	K111041	000
00846832056828	K111041	000
00846832056811	K111041	000
00846832056965	K111041	000
00846832056972	K111041	000
00846832056989	K111041	000
00846832057139	K111041	000
00846832057122	K111041	000
00846832057115	K111041	000
00846832057108	K111041	000
00846832057092	K111041	000
00846832057085	K111041	000
00846832057078	K111041	000
00846832057061	K111041	000
00846832057054	K111041	000
00846832057047	K111041	000
00846832057030	K111041	000
00846832057023	K111041	000
00846832057016	K111041	000
00846832057009	K111041	000
00846832056996	K111041	000
00846832056804	K111041	000