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 |