GENEX

Filler, Bone Void, Calcium Compound

BIOCOMPOSITES LTD.

The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Genex.

Pre-market Notification Details

• Device ID: K082381
• 510k Number: K082381
• Device Name: GENEX
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl
• Contact: Simon Fitzer
• Correspondent: Simon Fitzer; BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-19
• Decision Date: 2008-11-14
• Summary: summary