The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Trochanteric Reattachment Device (standard) And (long), Model 501-066, 501-067.
| Device ID | K001709 |
| 510k Number | K001709 |
| Device Name: | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Amy H Mommaerts |
| Correspondent | Amy H Mommaerts 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 | 2000-06-05 |
| Decision Date | 2000-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679498807S0 | K001709 | 000 |
| H679498806S0 | K001709 | 000 |