The following data is part of a premarket notification filed by Spineart with the FDA for Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-ca 12 05-s, Mos-ca 12 O6-s.
| Device ID | K091873 |
| 510k Number | K091873 |
| Device Name: | TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-09-18 |
| Summary: | summary |