The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Newdeal Ankle Nail.
| Device ID | K050882 |
| 510k Number | K050882 |
| Device Name: | NEWDEAL ANKLE NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-07 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044482 | K050882 | 000 |
| 10381780044567 | K050882 | 000 |
| M248500350ND1 | K050882 | 000 |
| 10381780044543 | K050882 | 000 |
| M248500250ND1 | K050882 | 000 |
| M248500180ND1 | K050882 | 000 |
| M248500150ND1 | K050882 | 000 |
| 10381780125860 | K050882 | 000 |