The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet Ac-t Secured Anterior Cervical Cage And Associated Instrumentation.
| Device ID | K141314 |
| 510k Number | K141314 |
| Device Name: | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva 15, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva 15, 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 | 2014-05-20 |
| Decision Date | 2014-09-29 |
| Summary: | summary |