The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (rti Surgical, Inc.) with the FDA for Nerve Monitoring Cable System.
| Device ID | K142438 |
| 510k Number | K142438 |
| Device Name: | Nerve Monitoring Cable System |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Contact | Sarah Mcintyre |
| Correspondent | Sarah Mcintyre Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Product Code | PDQ |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GXZ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468049393 | K142438 | 000 |