The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteo Ic Femoral And Tibial Nails And Osteo Retrograde/antegrade Femoral Nails With T2 Locking Screws.
| Device ID | K011622 |
| 510k Number | K011622 |
| Device Name: | OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-06-15 |
| Summary: | summary |