Perla® Posterior Cervico-Thoracic Fixation System

Orthosis, Cervical Pedicle Screw Spinal Fixation

SPINEART

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

Pre-market Notification Details

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• Device ID: K190071
• 510k Number: K190071
• Device Name: Perla® Posterior Cervico-Thoracic Fixation System
• Classification: Orthosis, Cervical Pedicle Screw Spinal Fixation
• 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
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-15
• Decision Date: 2019-02-25
• Summary: summary