The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Posterior Cervico-thoracic System.
| Device ID | K092295 |
| 510k Number | K092295 |
| Device Name: | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Emily M Downs |
| Correspondent | Emily M Downs PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2010-02-19 |
| Summary: | summary |