The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Spinous Process Fusion Plate.
| Device ID | K101525 |
| 510k Number | K101525 |
| Device Name: | PIONEER SPINOUS PROCESS FUSION PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PIONEER SURGICAL TECHNOLOGY 5 HEMINGWAY LANE West Newbury, MA 01985 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands PIONEER SURGICAL TECHNOLOGY 5 HEMINGWAY LANE West Newbury, MA 01985 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-10-22 |
| Summary: | summary |