The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Tibiaxys System.
| Device ID | K073375 |
| 510k Number | K073375 |
| Device Name: | NEWDEAL TIBIAXYS SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith O'grady |
| Correspondent | Judith 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 | 2007-12-03 |
| Decision Date | 2008-02-21 |
| Summary: | summary |