The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Vertebral Body Replacement Device (pioneer Vertebral Spacer).
| Device ID | K043206 |
| 510k Number | K043206 |
| Device Name: | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-19 |
| Decision Date | 2005-01-21 |
| Summary: | summary |