The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Lowtop Spinal Rod System.
| Device ID | K080504 |
| 510k Number | K080504 |
| Device Name: | PIONEER LOWTOP SPINAL ROD SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Jonathan M Gilbert |
| Correspondent | Jonathan M Gilbert PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-03-20 |
| Summary: | summary |