The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Spl Crimp System.
| Device ID | K002110 |
| 510k Number | K002110 |
| Device Name: | SPL CRIMP SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Amy H Mommaerts |
| Correspondent | Amy H Mommaerts PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-12 |
| Decision Date | 2000-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98149199201S0 | K002110 | 000 |
| H98149199101S0 | K002110 | 000 |
| H98129199201S0 | K002110 | 000 |
| H98129199101S0 | K002110 | 000 |