STAYFUSE
Screw, Fixation, Bone
PIONEER SURGICAL TECHNOLOGY
The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Stayfuse.
Pre-market Notification Details
| Device ID | K990804 |
| 510k Number | K990804 |
| Device Name: | STAYFUSE |
| Classification | Screw, Fixation, Bone |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Burns Severson |
| Correspondent | Burns Severson 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 | 1999-03-10 |
| Decision Date | 1999-04-29 |
| Summary: | summary |
Trademark Results [STAYFUSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAYFUSE 76007513 2611402 Dead/Cancelled |
TORNIER, INC. 2000-03-23 |
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