The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Bone Plate With Cables.
| Device ID | K972223 |
| 510k Number | K972223 |
| Device Name: | BONE PLATE WITH CABLES |
| Classification | Plate, Fixation, Bone |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE P.O. BOX 627 Marquette,, MI 49855 |
| Contact | Burns Severson |
| Correspondent | Burns Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE P.O. BOX 627 Marquette,, MI 49855 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-13 |
| Decision Date | 1997-09-10 |
| Summary: | summary |