The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Multiloc Proximal Humeral Nailing System.
| Device ID | K103002 |
| 510k Number | K103002 |
| Device Name: | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2010-10-08 |
| Decision Date | 2011-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679030190060 | K103002 | 000 |
| H679040190260 | K103002 | 000 |
| H67904019026S0 | K103002 | 000 |
| H679040190280 | K103002 | 000 |
| H67904019028S0 | K103002 | 000 |
| H679040190300 | K103002 | 000 |
| H67904019030S0 | K103002 | 000 |
| H679040190320 | K103002 | 000 |
| H67904019032S0 | K103002 | 000 |
| H679040190340 | K103002 | 000 |
| H67904019034S0 | K103002 | 000 |
| H679040190360 | K103002 | 000 |
| H67904019036S0 | K103002 | 000 |
| H67904019024S0 | K103002 | 000 |
| H679040190240 | K103002 | 000 |
| H679030190070 | K103002 | 000 |
| H679030190080 | K103002 | 000 |
| H679030190090 | K103002 | 000 |
| H679030190240 | K103002 | 000 |
| H67904016034S0 | K103002 | 000 |
| H67904016035S0 | K103002 | 000 |
| H67904016038S0 | K103002 | 000 |
| H67904016039S0 | K103002 | 000 |
| H679040190200 | K103002 | 000 |
| H67904019020S0 | K103002 | 000 |
| H679040190220 | K103002 | 000 |
| H67904019022S0 | K103002 | 000 |
| H679040190380 | K103002 | 000 |
| H67904019038S0 | K103002 | 000 |
| H679040190540 | K103002 | 000 |
| H67904019054S0 | K103002 | 000 |
| H679040190560 | K103002 | 000 |
| H67904019056S0 | K103002 | 000 |
| H679040190580 | K103002 | 000 |
| H67904019058S0 | K103002 | 000 |
| H679040190600 | K103002 | 000 |
| H67904019060S0 | K103002 | 000 |
| H67904019000S0 | K103002 | 000 |
| H67904019002S0 | K103002 | 000 |
| H67904019005S0 | K103002 | 000 |
| H67904019010S0 | K103002 | 000 |
| H67904019052S0 | K103002 | 000 |
| H679040190520 | K103002 | 000 |
| H679040190400 | K103002 | 000 |
| H67904019040S0 | K103002 | 000 |
| H679040190420 | K103002 | 000 |
| H67904019042S0 | K103002 | 000 |
| H679040190440 | K103002 | 000 |
| H67904019044S0 | K103002 | 000 |
| H679040190460 | K103002 | 000 |
| H67904019046S0 | K103002 | 000 |
| H679040190480 | K103002 | 000 |
| H67904019048S0 | K103002 | 000 |
| H679040190500 | K103002 | 000 |
| H67904019050S0 | K103002 | 000 |
| H67904019015S0 | K103002 | 000 |