The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Surgical Technology Extended Gtr, Model 501-601.
| Device ID | K000734 |
| 510k Number | K000734 |
| Device Name: | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Amy Mommaerts |
| Correspondent | Amy Mommaerts PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-07 |
| Decision Date | 2000-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468064075 | K000734 | 000 |
| 00846468064068 | K000734 | 000 |
| 00846468064051 | K000734 | 000 |
| 00846468064044 | K000734 | 000 |