The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer System Gtr(greater Trochanteer Reattachment) Device.
| Device ID | K961267 |
| 510k Number | K961267 |
| Device Name: | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Burns Severson |
| Correspondent | Burns Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-02 |
| Decision Date | 1996-06-27 |
| Summary: | summary |