The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Posterior Occipito-cervico-thoracic (oct) System.
| Device ID | K121725 |
| 510k Number | K121725 |
| Device Name: | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | 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 | 2012-06-12 |
| Decision Date | 2012-11-07 |
| Summary: | summary |