The following data is part of a premarket notification filed by Sig Medical Corporation with the FDA for Advantagerib System.
| Device ID | K183317 |
| 510k Number | K183317 |
| Device Name: | AdvantageRib System |
| Classification | Plate, Fixation, Bone |
| Applicant | SIG Medical Corporation 238 East Chocolate Avenue, Suite 2 Hershey, PA 17033 |
| Contact | Andrew Davison |
| Correspondent | Lauren Smith JALEX Medical, LLC. 30311 Clemens Road, Suite #5D Westlake, OH 44145 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-02-14 |
| Summary: | summary |