The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Basal Dorsal Plates.
| Device ID | K063831 |
| 510k Number | K063831 |
| Device Name: | BASAL DORSAL PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-02-07 |
| Summary: | summary |