SCARLET® AC-T Secured Anterior Cervical Cage

Intervertebral Fusion Device With Bone Graft, 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: K190322
• 510k Number: K190322
• Device Name: SCARLET® AC-T Secured Anterior Cervical Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• 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: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-13
• Decision Date: 2019-03-04