NANOGEN

Bone Grafting Material, Synthetic

ORTHOGEN, LLC

The following data is part of a premarket notification filed by Orthogen, Llc with the FDA for Nanogen.

Pre-market Notification Details

• Device ID: K102208
• 510k Number: K102208
• Device Name: NANOGEN
• Classification: Bone Grafting Material, Synthetic
• Applicant: ORTHOGEN, LLC 505 MORRIS AVENUE, SUITE 104 Springfield, NJ 07081
• Contact: Harold Alexander
• Correspondent: Harold Alexander; ORTHOGEN, LLC 505 MORRIS AVENUE, SUITE 104 Springfield, NJ 07081
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-05
• Decision Date: 2011-05-06
• Summary: summary