The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. with the FDA for Pioneer Crossfuse Ii Ibf/vbr System.
| Device ID | K112496 |
| 510k Number | K112496 |
| Device Name: | PIONEER CROSSFUSE II IBF/VBR SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC. 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Emily M Downs |
| Correspondent | Emily M Downs PIONEER SURGICAL TECHNOLOGY, INC. 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-09-28 |
| Summary: | summary |