The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Femoral Neck System.
| Device ID | K172872 |
| 510k Number | K172872 |
| Device Name: | DePuy Synthes Femoral Neck System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DePuy Synthes Luzernstrasse 21 Zuchwil, CH 4528 |
| Contact | Ana Sala Roca |
| Correspondent | Ana Sala Roca DePuy Synthes Luzernstrasse 21 Zuchwil, CH 4528 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982274274 | K172872 | 000 |
| 10886982343680 | K172872 | 000 |
| 10886982335524 | K172872 | 000 |
| 07611819657342 | K172872 | 000 |
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| 10886982274809 | K172872 | 000 |