The following data is part of a premarket notification filed by Dvo Extremity Solutions, Llc with the FDA for Wrist Fusion Plate.
| Device ID | K052754 |
| 510k Number | K052754 |
| Device Name: | WRIST FUSION PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-10-27 |
| Summary: | summary |