The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Release Laminoplasty Fixation System.
| Device ID | K153735 |
| 510k Number | K153735 |
| Device Name: | Release Laminoplasty Fixation System |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| 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 | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-01-21 |
| Summary: | summary |