The following data is part of a premarket notification filed by Sig Medical Corp. with the FDA for Advantagerib Anterior System.
| Device ID | K182179 |
| 510k Number | K182179 |
| Device Name: | AdvantageRib Anterior System |
| Classification | Plate, Fixation, Bone |
| Applicant | SIG Medical Corp. 238 E. Chocolate Avenue Suite 2 Hershey, PA 17033 |
| Contact | Andrew Davison |
| Correspondent | Jennifer Palinchik JALEX Medical, LLC 30331 Clemens Road, Suite #5D Westlake, OH 44145 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2018-11-16 |
| Summary: | summary |