The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Aspect Anterior Cervical Plate Model 24-series.
| Device ID | K111528 |
| 510k Number | K111528 |
| Device Name: | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Sarah Mcintyre |
| Correspondent | Sarah Mcintyre PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-08-24 |
| Summary: | summary |