PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

Posterior Cervical Screw System

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Perla® Posterior Occipito-cervico-thoracic Fixation System.

Pre-market Notification Details

• Device ID: K200571
• 510k Number: K200571
• Device Name: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
• Classification: Posterior Cervical Screw System
• Applicant: SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-04
• Decision Date: 2020-05-01