The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc D.b.a Resolve Surgical Tech with the FDA for Dvr® Crosslock Wrist Spanning Plate (131849181).
| Device ID | K220244 |
| 510k Number | K220244 |
| Device Name: | DVR® Crosslock Wrist Spanning Plate (131849181) |
| Classification | Plate, Fixation, Bone |
| Applicant | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech 375 River Park Circle Marquette, MI 49855 |
| Contact | Jaclyn Holli |
| Correspondent | Jaclyn Holli Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech 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 | 2022-01-28 |
| Decision Date | 2022-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468005108 | K220244 | 000 |