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 |