The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Sternal Assist Implant System.
| Device ID | K120016 |
| 510k Number | K120016 |
| Device Name: | PIONEER STERNAL ASSIST IMPLANT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Sarah Mcintyre |
| Correspondent | Sarah Mcintyre PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE 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 | 2012-01-03 |
| Decision Date | 2012-07-26 |
| Summary: | summary |