Sphynx™

Appliance, Fixation, Spinal Intervertebral Body

Eden Spine LLC

The following data is part of a premarket notification filed by Eden Spine Llc with the FDA for Sphynx™.

Pre-market Notification Details

• Device ID: K160982
• 510k Number: K160982
• Device Name: Sphynx™
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Eden Spine LLC 377 Maitland Avenue, SUite 1015 Atlamonte Springs, FL 32701
• Contact: Guillaume Viallaneix
• Correspondent: Tamala J. Wampler; Novus Management Group, LLC 6686 Dimmick Road West Chester, OH 45069
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-07
• Decision Date: 2016-12-22
• Summary: summary