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 |