The following data is part of a premarket notification filed by Spineart with the FDA for Tryptik Cc Anterior Intersomatic Cervical Cage.
| Device ID | K122366 |
| 510k Number | K122366 |
| Device Name: | TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Frank Pennesi |
| Correspondent | Frank 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-10-04 |
| Summary: | summary |