Origin™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Orthopaedic & Spine Development

The following data is part of a premarket notification filed by Orthopaedic & Spine Development with the FDA for Origin™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K193494
• 510k Number: K193494
• Device Name: Origin™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Orthopaedic & Spine Development Chemin De Fontanille BP11211 Avignon Cedex 9, FR 84911
• Contact: Nicolas Palillon
• Correspondent: Roger N White; Phiama, Inc 236 McKinley Park Lane Louisville, CO 80027
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-17
• Decision Date: 2020-04-06