The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Streamline Oct Occipito-cervico-thoracic System.
| Device ID | K161498 |
| 510k Number | K161498 |
| Device Name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Classification | Posterior Cervical Screw System |
| Applicant | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Contact | Sarah Pleaugh |
| Correspondent | Sarah Pleaugh Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468083625 | K161498 | 000 |
| 00846468077969 | K161498 | 000 |
| 00846468083663 | K161498 | 000 |
| 00846468083656 | K161498 | 000 |
| 00846468083649 | K161498 | 000 |
| 00846468083632 | K161498 | 000 |
| 00846468083601 | K161498 | 000 |
| 00846468083595 | K161498 | 000 |
| 00846468083588 | K161498 | 000 |
| 00846468077976 | K161498 | 000 |
| 00846468077983 | K161498 | 000 |
| 00846468077990 | K161498 | 000 |
| 00846468083618 | K161498 | 000 |
| 00846468083564 | K161498 | 000 |
| 00846468083557 | K161498 | 000 |
| 00846468078041 | K161498 | 000 |
| 00846468078034 | K161498 | 000 |
| 00846468078027 | K161498 | 000 |
| 00846468078010 | K161498 | 000 |
| 00846468078003 | K161498 | 000 |
| 00846468083571 | K161498 | 000 |