CONNEXUS

Filler, Bone Void, Calcium Compound

ISOTIS ORTHOBIOLOGICS, INC

The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Connexus.

Pre-market Notification Details

• Device ID: K050690
• 510k Number: K050690
• Device Name: CONNEXUS
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618
• Contact: Paul Doner
• Correspondent: Paul Doner; ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-17
• Decision Date: 2005-07-07
• Summary: summary