BIOHORIZONS SINGLE-STAGE IMPLANT 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 Biohorizons Single-stage Implant System.

Pre-market Notification Details

• Device ID: K073282
• 510k Number: K073282
• Device Name: BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244
• Contact: Winston Greer
• Correspondent: Winston Greer; BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-21
• Decision Date: 2008-02-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847236013165	K073282	000
00847236008031	K073282	000
00847236008093	K073282	000
00847236008109	K073282	000
00847236008116	K073282	000
00847236008185	K073282	000
00847236008192	K073282	000
00847236008208	K073282	000
00847236008277	K073282	000
00847236008284	K073282	000
00847236008291	K073282	000
00847236008314	K073282	000
00847236008024	K073282	000