The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Interphalangeal Implant.
| Device ID | K103623 |
| 510k Number | K103623 |
| Device Name: | NEWDEAL INTERPHALANGEAL IMPLANT |
| Classification | Pin, Fixation, Smooth |
| Applicant | NEWDEAL SAS IMMEUBLE SEQUOIA 2, 97 ALLEE ALEXANDRE BORODINE Parc Technologique De La Prte, FR 69800 |
| Contact | Marilyse Latour |
| Correspondent | Marilyse Latour NEWDEAL SAS IMMEUBLE SEQUOIA 2, 97 ALLEE ALEXANDRE BORODINE Parc Technologique De La Prte, FR 69800 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-10 |
| Decision Date | 2012-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780125877 | K103623 | 000 |