The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Intess Lumbar Cage.
| Device ID | K123100 |
| 510k Number | K123100 |
| Device Name: | INTESS LUMBAR CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2013-03-28 |
| Summary: | summary |