The following data is part of a premarket notification filed by A&e Medical Corporation with the FDA for Thorecon Rigid Fixation System.
| Device ID | K181607 |
| 510k Number | K181607 |
| Device Name: | Thorecon Rigid Fixation System |
| Classification | Cerclage, Fixation |
| Applicant | A&E Medical Corporation 5206 Asbury Road, PO Box 758 Farmingdale, NJ 07727 |
| Contact | Dana Rodriguez |
| Correspondent | Sarah Pleaugh RTI Surgical, Inc 375 River Park Circle Marquette, MI 49855 |
| Product Code | JDQ |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-10-12 |
| Summary: | summary |