The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Lapidus Plate.
| Device ID | K060476 |
| 510k Number | K060476 |
| Device Name: | LAPIDUS PLATE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-23 |
| Decision Date | 2006-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044055 | K060476 | 000 |
| 10381780044048 | K060476 | 000 |
| 10381780044031 | K060476 | 000 |
| 10381780044024 | K060476 | 000 |