ROMEO® 2 Posterior Osteosynthesis System

Thoracolumbosacral Pedicle Screw System

Spineart

The following data is part of a premarket notification filed by Spineart with the FDA for Romeo® 2 Posterior Osteosynthesis System.

Pre-market Notification Details

• Device ID: K172101
• 510k Number: K172101
• Device Name: ROMEO® 2 Posterior Osteosynthesis System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Spineart 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates, CH 1228
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-12
• Decision Date: 2017-09-26
• Summary: summary