ORTHOSTAT

Wax, Bone

ORTHOCON, INC.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Orthostat.

Pre-market Notification Details

• Device ID: K091121
• 510k Number: K091121
• Device Name: ORTHOSTAT
• Classification: Wax, Bone
• Applicant: ORTHOCON, INC. 675 US HIGHWAY ONE North Brunswick, NJ 08902
• Contact: Kenneth A Collins
• Correspondent: Kenneth A Collins; ORTHOCON, INC. 675 US HIGHWAY ONE North Brunswick, NJ 08902
• Product Code: MTJ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-17
• Decision Date: 2009-04-28
• Summary: summary