The following data is part of a premarket notification filed by A & E Medical Corporation with the FDA for Sternal Cable System.
| Device ID | K180582 |
| 510k Number | K180582 |
| Device Name: | Sternal Cable System |
| Classification | Cerclage, Fixation |
| Applicant | A & E Medical Corporation 5206 Asbury Road Farmingdale, NJ 07727 |
| Contact | Hollie Johnson |
| Correspondent | Sarah Pleaugh RTI Surgical, Inc. 375 River Park Circle Marquette, MI 49855 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-05-31 |
| Summary: | summary |