The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Quantum/streamline Tl Mis Spinal System.
| Device ID | K093771 |
| 510k Number | K093771 |
| Device Name: | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Emily Downs |
| Correspondent | Emily Downs PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-08 |
| Decision Date | 2010-08-10 |
| Summary: | summary |