CRYSTAL

Intervertebral Fusion Device With Bone Graft, Cervical

SPINAL ELEMENTS, INC.

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

Pre-market Notification Details

• Device ID: K073351
• 510k Number: K073351
• Device Name: CRYSTAL
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010
• Contact: Kerri Dimartino
• Correspondent: Kerri Dimartino; SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-29
• Decision Date: 2008-01-24
• Summary: summary