The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Laboratories Bone Plate With Cerclage Cables.
| Device ID | K940729 |
| 510k Number | K940729 |
| Device Name: | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE P.O. BOX 627 Marquette,, MI 49855 |
| Contact | Burns O Severson |
| Correspondent | Burns O Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE P.O. BOX 627 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 | 1994-02-18 |
| Decision Date | 1994-12-21 |