The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for E-matrix Graft Bone Extender.
| Device ID | K083449 |
| 510k Number | K083449 |
| Device Name: | E-MATRIX GRAFT BONE EXTENDER |
| 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 | 2008-11-21 |
| Decision Date | 2009-06-12 |
| Summary: | summary |