The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Tritium Sternal Cable Plate System.
| Device ID | K193468 |
| 510k Number | K193468 |
| Device Name: | Tritium Sternal Cable Plate System |
| Classification | Cerclage, Fixation |
| Applicant | Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Contact | Linda Busklein |
| Correspondent | Peter Browne A&E Medical Corporation 5206 Asbury Road, PO BOX 758 Farmingdale, NJ 07727 |
| Product Code | JDQ |
| 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 | 2019-12-16 |
| Decision Date | 2020-03-12 |