The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Lisfranc Plate.
| Device ID | K060474 |
| 510k Number | K060474 |
| Device Name: | LISFRANC 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 | 2006-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780048497 | K060474 | 000 |
| 10381780044017 | K060474 | 000 |
| 10381780044000 | K060474 | 000 |
| 10381780043997 | K060474 | 000 |
| 10381780043980 | K060474 | 000 |
| 10381780043973 | K060474 | 000 |
| 10381780043966 | K060474 | 000 |