The following data is part of a premarket notification filed by Synthes Usa with the FDA for Set Screw For Ti Trochanteric Fixation Nail(tfn).
| Device ID | K120083 |
| 510k Number | K120083 |
| Device Name: | SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Thomas N Shea |
| Correspondent | Thomas N Shea 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 | 2012-01-11 |
| Decision Date | 2012-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67904032002S0 | K120083 | 000 |
| H67904032001S0 | K120083 | 000 |
| H67904032000S0 | K120083 | 000 |