The following data is part of a premarket notification filed by Astura Medical, Llc with the FDA for Olympic Posterior Spinal Fixation System.
| Device ID | K181139 |
| 510k Number | K181139 |
| Device Name: | OLYMPIC Posterior Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Astura Medical, LLC 3168 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical, LLC 3168 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-07-06 |