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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640185341807	K190322	000
07640185341791	K190322	000
07640185341784	K190322	000
07640185341777	K190322	000
07640185341760	K190322	000
07640185341753	K190322	000
07640185341746	K190322	000
07640185341739	K190322	000