The following data is part of a premarket notification filed by Osteo Vasive Llc with the FDA for A-link Z.
| Device ID | K133827 |
| 510k Number | K133827 |
| Device Name: | A-LINK Z |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | OSTEO VASIVE LLC 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas OSTEO VASIVE LLC 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-17 |
| Decision Date | 2014-11-17 |
| Summary: | summary |