The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes Tfna Augmentation System.
| Device ID | K160167 |
| 510k Number | K160167 |
| Device Name: | DePuy Synthes TFNA Augmentation System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Christopher J. Medberry |
| Correspondent | Christopher J. Medberry Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679040384050 | K160167 | 000 |
| H67904038175S0 | K160167 | 000 |
| H679040381800 | K160167 | 000 |
| H67904038180S0 | K160167 | 000 |
| H679040381850 | K160167 | 000 |
| H67904038185S0 | K160167 | 000 |
| H679040381900 | K160167 | 000 |
| H67904038190S0 | K160167 | 000 |
| H679040381950 | K160167 | 000 |
| H67904038195S0 | K160167 | 000 |
| H679040382000 | K160167 | 000 |
| H67904038200S0 | K160167 | 000 |
| H679040382050 | K160167 | 000 |
| H679040381750 | K160167 | 000 |
| H67904038170S0 | K160167 | 000 |
| H67904038405S0 | K160167 | 000 |
| H679040384100 | K160167 | 000 |
| H67904038410S0 | K160167 | 000 |
| H679040384150 | K160167 | 000 |
| H67904038415S0 | K160167 | 000 |
| H679040384200 | K160167 | 000 |
| H67904038420S0 | K160167 | 000 |
| H679040384250 | K160167 | 000 |
| H67904038425S0 | K160167 | 000 |
| H679040384300 | K160167 | 000 |
| H67904038430S0 | K160167 | 000 |
| H679040381700 | K160167 | 000 |
| H67904038205S0 | K160167 | 000 |
| H679040382100 | K160167 | 000 |
| H67904038380S0 | K160167 | 000 |
| H679040383850 | K160167 | 000 |
| H67904038385S0 | K160167 | 000 |
| H679040383900 | K160167 | 000 |
| H67904038390S0 | K160167 | 000 |
| H679040383950 | K160167 | 000 |
| H67904038395S0 | K160167 | 000 |
| H679040384000 | K160167 | 000 |
| H67904038400S0 | K160167 | 000 |
| 10886982296054 | K160167 | 000 |
| 10886982296061 | K160167 | 000 |
| 10886982296078 | K160167 | 000 |
| H679040383800 | K160167 | 000 |
| H67904038375S0 | K160167 | 000 |
| H67904038210S0 | K160167 | 000 |
| H679040382150 | K160167 | 000 |
| H67904038215S0 | K160167 | 000 |
| H679040382200 | K160167 | 000 |
| H67904038220S0 | K160167 | 000 |
| H679040382250 | K160167 | 000 |
| H67904038225S0 | K160167 | 000 |
| H679040382300 | K160167 | 000 |
| H67904038230S0 | K160167 | 000 |
| H679040383700 | K160167 | 000 |
| H67904038370S0 | K160167 | 000 |
| H679040383750 | K160167 | 000 |
| 10886982296085 | K160167 | 000 |