The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc., Dba Rti Surgical with the FDA for Dac Dynamic Active Compression Plate.
| Device ID | K200513 |
| 510k Number | K200513 |
| Device Name: | DAC Dynamic Active Compression Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | Pioneer Surgical Technology, Inc., DBA RTI Surgical 375 River Park Circle Marquette, MI 49855 |
| Contact | Linda Busklein |
| Correspondent | Sarah Pleaugh Pioneer Surgical Technology, Inc., DBA RTI Surgical 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 | 2020-03-02 |
| Decision Date | 2020-07-22 |