The following data is part of a premarket notification filed by Cardinal Spine, Llc with the FDA for Stgc-lordotic.
| Device ID | K142030 |
| 510k Number | K142030 |
| Device Name: | STGC-LORDOTIC |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | CARDINAL SPINE, LLC 12264 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Contact | Kevin A. Thomas |
| Correspondent | Kevin A. Thomas CARDINAL SPINE, LLC 12264 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2015-01-23 |
| Summary: | summary |