The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Lisfranc Plate.
| Device ID | K063820 |
| 510k Number | K063820 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780048480 | K063820 | 000 |
| M248285328SND1 | K063820 | 000 |
| 10381780049074 | K063820 | 000 |
| M248285332SND1 | K063820 | 000 |
| M248285334SND1 | K063820 | 000 |
| 10381780049685 | K063820 | 000 |
| 10381780049692 | K063820 | 000 |
| 10381780049708 | K063820 | 000 |
| 10381780049715 | K063820 | 000 |
| M248285326SND1 | K063820 | 000 |
| M248285324SND1 | K063820 | 000 |
| 10381780048992 | K063820 | 000 |
| 10381780048541 | K063820 | 000 |
| 10381780048558 | K063820 | 000 |
| 10381780048879 | K063820 | 000 |
| 10381780048893 | K063820 | 000 |
| M248285314SND1 | K063820 | 000 |
| M248285316SND1 | K063820 | 000 |
| M248285318SND1 | K063820 | 000 |
| 10381780048978 | K063820 | 000 |
| M248286314SND1 | K063820 | 000 |
| 10381780049739 | K063820 | 000 |
| 10381780049852 | K063820 | 000 |
| M248286328SND1 | K063820 | 000 |
| 10381780049876 | K063820 | 000 |
| 10381780049883 | K063820 | 000 |
| 10381780049890 | K063820 | 000 |
| M248286332SND1 | K063820 | 000 |
| 10381780049913 | K063820 | 000 |
| M248286334SND1 | K063820 | 000 |
| M248286326SND1 | K063820 | 000 |
| 10381780049838 | K063820 | 000 |
| M248286324SND1 | K063820 | 000 |
| M248286316SND1 | K063820 | 000 |
| 10381780049753 | K063820 | 000 |
| M248286318SND1 | K063820 | 000 |
| 10381780049777 | K063820 | 000 |
| 10381780049784 | K063820 | 000 |
| 10381780049791 | K063820 | 000 |
| M248286322SND1 | K063820 | 000 |
| 10381780049814 | K063820 | 000 |
| 10381780057543 | K063820 | 000 |