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 |