MODIFICATION TO THE MAESTRO SYSTEM

Implant, Endosseous, Root-form

BIOHORIZONS IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Modification To The Maestro System.

Pre-market Notification Details

• Device ID: K030463
• 510k Number: K030463
• Device Name: MODIFICATION TO THE MAESTRO SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243
• Contact: Winston Greer
• Correspondent: Winston Greer; BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-12
• Decision Date: 2003-02-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847236001896	K030463	000
00847236000035	K030463	000
00847236000066	K030463	000
00847236000080	K030463	000
00847236000103	K030463	000
00847236000127	K030463	000
00847236000158	K030463	000
00847236000165	K030463	000
00847236000172	K030463	000
00847236000189	K030463	000
00847236000196	K030463	000
00847236001865	K030463	000
00847236001872	K030463	000
00847236000011	K030463	000