The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. with the FDA for Pioneer Posterior Cervico Thoracic System.
| Device ID | K112757 |
| 510k Number | K112757 |
| Device Name: | PIONEER POSTERIOR CERVICO THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-22 |
| Decision Date | 2012-03-12 |
| Summary: | summary |