The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Trochanteric Fixation Nail (tfn) Screw.
| Device ID | K092646 |
| 510k Number | K092646 |
| Device Name: | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW |
| 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 | 2009-08-28 |
| Decision Date | 2009-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793574280 | K092646 | 000 |
| H67904032070S0 | K092646 | 000 |
| H67904032075S0 | K092646 | 000 |
| H67904032080S0 | K092646 | 000 |
| H67904032085S0 | K092646 | 000 |
| H67904032090S0 | K092646 | 000 |
| H67904032095S0 | K092646 | 000 |
| H67904032100S0 | K092646 | 000 |
| H67904032105S0 | K092646 | 000 |
| H67904032110S0 | K092646 | 000 |
| H67904032115S0 | K092646 | 000 |
| H67904032120S0 | K092646 | 000 |
| H67904032125S0 | K092646 | 000 |
| H67904032130S0 | K092646 | 000 |
| H6793570520 | K092646 | 000 |