XIPHOS

Intervertebral Fusion Device With Bone Graft, Lumbar

DIFUSION TECHNOLOGIES

The following data is part of a premarket notification filed by Difusion Technologies with the FDA for Xiphos.

Pre-market Notification Details

• Device ID: K123969
• 510k Number: K123969
• Device Name: XIPHOS
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: DIFUSION TECHNOLOGIES PO BOX 566 Chesterland, OH 44026 -2141
• Contact: Karen E Warden, Phd
• Correspondent: Karen E Warden, Phd; DIFUSION TECHNOLOGIES PO BOX 566 Chesterland, OH 44026 -2141
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-26
• Decision Date: 2013-02-07
• Summary: summary