The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Kalix Ii Implant.
| Device ID | K061765 |
| 510k Number | K061765 |
| Device Name: | KALIX II IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | NEWDEAL S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady NEWDEAL S.A. 311 ENTERPRISE DRIVE 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 | 2006-06-22 |
| Decision Date | 2006-07-18 |
| Summary: | summary |