The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Modification To Ttc Plates.
| Device ID | K070160 |
| 510k Number | K070160 |
| Device Name: | MODIFICATION TO TTC PLATES |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-02-08 |
| Summary: | summary |