The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Synthes Multiloc Humeral Nailing System.
| Device ID | K120807 |
| 510k Number | K120807 |
| Device Name: | SYNTHES MULTILOC HUMERAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES USA PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Rebecca Blank |
| Correspondent | Rebecca Blank 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 | 2012-03-16 |
| Decision Date | 2012-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679030190110 | K120807 | 000 |
| H67904016300S0 | K120807 | 000 |
| H67904016315S0 | K120807 | 000 |
| H67904017180S0 | K120807 | 000 |
| H67904017195S0 | K120807 | 000 |
| H67904017210S0 | K120807 | 000 |
| H67904017225S0 | K120807 | 000 |
| H67904017240S0 | K120807 | 000 |
| H67904017255S0 | K120807 | 000 |
| H67904017270S0 | K120807 | 000 |
| H67904016285S0 | K120807 | 000 |
| H67904016270S0 | K120807 | 000 |
| H679030190120 | K120807 | 000 |
| H679030190380 | K120807 | 000 |
| H679030190400 | K120807 | 000 |
| H67904016180S0 | K120807 | 000 |
| H67904016195S0 | K120807 | 000 |
| H67904016210S0 | K120807 | 000 |
| H67904016225S0 | K120807 | 000 |
| H67904016240S0 | K120807 | 000 |
| H67904016255S0 | K120807 | 000 |
| H67904017285S0 | K120807 | 000 |
| H67904017300S0 | K120807 | 000 |
| H67904017315S0 | K120807 | 000 |
| H67904019195S0 | K120807 | 000 |
| H67904019210S0 | K120807 | 000 |
| H67904019225S0 | K120807 | 000 |
| H67904019240S0 | K120807 | 000 |
| H67904019255S0 | K120807 | 000 |
| H67904019270S0 | K120807 | 000 |
| H67904019285S0 | K120807 | 000 |
| H67904019300S0 | K120807 | 000 |
| H67904019315S0 | K120807 | 000 |
| H67904019180S0 | K120807 | 000 |
| H67904018315S0 | K120807 | 000 |
| H67904018180S0 | K120807 | 000 |
| H67904018195S0 | K120807 | 000 |
| H67904018210S0 | K120807 | 000 |
| H67904018225S0 | K120807 | 000 |
| H67904018240S0 | K120807 | 000 |
| H67904018255S0 | K120807 | 000 |
| H67904018270S0 | K120807 | 000 |
| H67904018285S0 | K120807 | 000 |
| H67904018300S0 | K120807 | 000 |
| H679030190010 | K120807 | 000 |