The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Quantum/ Streamline Spinal System Model 02-series And 10-series.
| Device ID | K093692 |
| 510k Number | K093692 |
| Device Name: | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Emily M Downs |
| Correspondent | Emily M Downs PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | NKB |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-30 |
| Decision Date | 2010-08-11 |
| Summary: | summary |