The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Intess Cervical Cage System.
| Device ID | K133815 |
| 510k Number | K133815 |
| Device Name: | INTESS CERVICAL CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | KALITEC DIRECT, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb KALITEC DIRECT, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-04-16 |
| Summary: | summary |