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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640185341654	K190071	000
07640185341524	K190071	000
07640185341531	K190071	000
07640185341548	K190071	000
07640185341555	K190071	000
07640185341562	K190071	000
07640185341579	K190071	000
07640185341586	K190071	000
07640185341593	K190071	000
07640185341609	K190071	000
07640185341616	K190071	000
07640185341623	K190071	000
07640185341630	K190071	000
07640185341647	K190071	000
07640185341517	K190071	000