SCARLET® AC-T Secured Anterior Cervical Cage

Intervertebral Fusion Device With Integrated Fixation, Cervical

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet® Ac-t Secured Anterior Cervical Cage.

Pre-market Notification Details

• Device ID: K143214
• 510k Number: K143214
• Device Name: SCARLET® AC-T Secured Anterior Cervical Cage
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SPINEART lnternational Center Cointrin 20 Route De Pré-bois CP1813 Geneva, CH 1215
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART lnternational Center Cointrin 20 Route De Pré-bois CP1813 Geneva, CH 1215
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-10
• Decision Date: 2015-02-23
• Summary: summary