The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Qwix Positioning Screw.
| Device ID | K071639 |
| 510k Number | K071639 |
| Device Name: | QWIX POSITIONING SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-15 |
| Decision Date | 2007-07-09 |
| Summary: | summary |