LUCENT

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINAL ELEMENTS, INC.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lucent.

Pre-market Notification Details

• Device ID: K122967
• 510k Number: K122967
• Device Name: LUCENT
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010
• Contact: Benjamin A Kimball
• Correspondent: Benjamin A Kimball; SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-25
• Decision Date: 2013-02-21
• Summary: summary