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 | K150581 |
| 510k Number | K150581 |
| 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 | Sarah Pleaugh |
| Correspondent | Sarah Pleaugh Pioneer Surgical Technology, Inc. (DBA RTI Surgical, 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 | 2015-03-09 |
| Decision Date | 2015-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468066710 | K150581 | 000 |
| 00846468061654 | K150581 | 000 |
| 00846468061630 | K150581 | 000 |
| 00846468061623 | K150581 | 000 |
| 00846468061609 | K150581 | 000 |
| 00846468061593 | K150581 | 000 |
| 00846468061579 | K150581 | 000 |
| 00846468049775 | K150581 | 000 |
| 00846468049768 | K150581 | 000 |
| 00846468049751 | K150581 | 000 |
| 00191083005539 | K150581 | 000 |
| 00846468061661 | K150581 | 000 |
| 00846468061678 | K150581 | 000 |
| 00846468061685 | K150581 | 000 |
| 00846468063764 | K150581 | 000 |
| 00846468061814 | K150581 | 000 |
| 00846468061807 | K150581 | 000 |
| 00846468061784 | K150581 | 000 |
| 00846468061777 | K150581 | 000 |
| 00846468061753 | K150581 | 000 |
| 00846468061746 | K150581 | 000 |
| 00846468061722 | K150581 | 000 |
| 00846468061715 | K150581 | 000 |
| 00846468061692 | K150581 | 000 |
| 00191083005522 | K150581 | 000 |