The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Odalys Pedicle Screw System.
| Device ID | K111370 |
| 510k Number | K111370 |
| Device Name: | ODALYS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-09-21 |
| Summary: | summary |