LOTUS

Appliance, Fixation, Spinal Interlaminal

SPINAL ELEMENTS, INC.

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

Pre-market Notification Details

• Device ID: K131427
• 510k Number: K131427
• Device Name: LOTUS
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE STE 200 Carlsbad, CA 92010
• Contact: Benjamin A Kimball
• Correspondent: Benjamin A Kimball; SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE STE 200 Carlsbad, CA 92010
• Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-17
• Decision Date: 2013-10-24
• Summary: summary