The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Trochanteric Fixation Nail (tfn) System, Additional Helical Blades.
| Device ID | K070294 |
| 510k Number | K070294 |
| Device Name: | SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-31 |
| Decision Date | 2007-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679456650S0 | K070294 | 000 |
| H679456310S0 | K070294 | 000 |
| H679456300S0 | K070294 | 000 |