Crystal ®; Mosaic ®; Vertu ®

Intervertebral Fusion Device With Integrated Fixation, Cervical

SPINAL ELEMENTS, INC.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Crystal ®; Mosaic ®; Vertu ®.

Pre-market Notification Details

• Device ID: K133218
• 510k Number: K133218
• Device Name: Crystal ®; Mosaic ®; Vertu ®
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE, STE 200 Carlsbad, CA 92010
• Contact: Julie Lamothe
• Correspondent: Julie Lamothe; SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE, STE 200 Carlsbad, CA 92010
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-18
• Decision Date: 2014-12-10
• Summary: summary