The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (rti Surgical, I with the FDA for Streamline Oct Occipito-cervico-thoracic System.
| Device ID | K133374 |
| 510k Number | K133374 |
| Device Name: | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Sarah Mcintyre |
| Correspondent | Sarah Mcintyre PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-01 |
| Decision Date | 2014-03-19 |
| Summary: | summary |