The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Surgical Technology Nanoss Bvf-e, Models 5, 10, 20cc.
| Device ID | K081558 |
| 510k Number | K081558 |
| Device Name: | PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-03 |
| Decision Date | 2008-08-25 |
| Summary: | summary |