The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for S2 Femoral A/r Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail.
| Device ID | K113409 |
| 510k Number | K113409 |
| Device Name: | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430 |
| Contact | Juma Hoshino |
| Correspondent | Juma Hoshino HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-02-15 |
| Summary: | summary |