INTERFACE

Filler, Bone Void, Calcium Compound

BIOSTRUCTURES

The following data is part of a premarket notification filed by Biostructures with the FDA for Interface.

Pre-market Notification Details

• Device ID: K092541
• 510k Number: K092541
• Device Name: INTERFACE
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BIOSTRUCTURES 26552 TAMPICO PLACE Mission Viejo, CA 92691
• Contact: Dave Balding
• Correspondent: Dave Balding; BIOSTRUCTURES 26552 TAMPICO PLACE Mission Viejo, CA 92691
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-19
• Decision Date: 2010-11-09
• Summary: summary