The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Tritium Sternal Cable Plate System.
| Device ID | K133785 |
| 510k Number | K133785 |
| Device Name: | TRITIUM STERNAL CABLE PLATE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Emily Downs |
| Correspondent | Emily Downs PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| 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 | 2013-12-12 |
| Decision Date | 2014-01-27 |
| Summary: | summary |