The following data is part of a premarket notification filed by Allez Spine, Llc with the FDA for Laguna Polyaxial Pedicle Screw System.
| Device ID | K083826 |
| 510k Number | K083826 |
| Device Name: | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine, CA 92612 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine, CA 92612 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-01-22 |
| Summary: | summary |