Converge

Plate, Fixation, Bone

BIOMEDICAL ENTERPRISES, INC

The following data is part of a premarket notification filed by Biomedical Enterprises, Inc with the FDA for Converge.

Pre-market Notification Details

• Device ID: K153573
• 510k Number: K153573
• Device Name: Converge
• Classification: Plate, Fixation, Bone
• Applicant: BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR., STE 205 San Antonio, TX 78245
• Contact: Joe Soward
• Correspondent: Joe Soward; BIOMEDICAL ENTERPRISES, INC. 14785 OMICRON DR., STE 205 San Antonio, TX 78245
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-15
• Decision Date: 2016-08-11
• Summary: summary