PATHWAY

Intervertebral Fusion Device With Bone Graft, Lumbar

CUSTOM SPINE, INC.

The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway.

Pre-market Notification Details

• Device ID: K080281
• 510k Number: K080281
• Device Name: PATHWAY
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054
• Contact: Saad Attiyah
• Correspondent: Saad Attiyah; CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-04
• Decision Date: 2008-05-01
• Summary: summary