The following data is part of a premarket notification filed by Deo Volente Orthopaedics, Llc with the FDA for Dorsal Intramedullary Plate.
| Device ID | K042437 |
| 510k Number | K042437 |
| Device Name: | DORSAL INTRAMEDULLARY PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | DEO VOLENTE ORTHOPAEDICS, LLC P.O. BOX 83 Warsaw, IN 46581 |
| Contact | Dina L Weissman, J.d. |
| Correspondent | Dina L Weissman, J.d. DEO VOLENTE ORTHOPAEDICS, LLC P.O. BOX 83 Warsaw, IN 46581 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-10-08 |
| Summary: | summary |