The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Release Laminoplasty Plating System.
| Device ID | K113218 |
| 510k Number | K113218 |
| Device Name: | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Sarah Mclntyre |
| Correspondent | Sarah Mclntyre PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2012-01-26 |
| Summary: | summary |