The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Evos Cabling System.
| Device ID | K201497 |
| 510k Number | K201497 |
| Device Name: | EVOS Cabling System |
| Classification | Cerclage, Fixation |
| Applicant | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Contact | Sarah Pleaugh |
| Correspondent | Jaclyn Holli Pioneer Surgical Technology, Inc. (DBA 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 | 2020-06-05 |
| Decision Date | 2020-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191083003979 | K201497 | 000 |