The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Stayfuse Gt-ip.
| Device ID | K022726 |
| 510k Number | K022726 |
| Device Name: | STAYFUSE GT-IP |
| Classification | Screw, Fixation, Bone |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Kathy Moran |
| Correspondent | Kathy Moran PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-16 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832009688 | K022726 | 000 |
| 00846832009589 | K022726 | 000 |
| 00846832009596 | K022726 | 000 |
| 00846832009602 | K022726 | 000 |
| 00846832009619 | K022726 | 000 |
| 00846832009626 | K022726 | 000 |
| 00846832009633 | K022726 | 000 |
| 00846832009640 | K022726 | 000 |
| 00846832009657 | K022726 | 000 |
| 00846832009664 | K022726 | 000 |
| 00846832009671 | K022726 | 000 |
| 00846832009572 | K022726 | 000 |