The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for S2 Femoral Nail.
| Device ID | K021026 |
| 510k Number | K021026 |
| Device Name: | S2 FEMORAL NAIL |
| 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 | 2002-03-29 |
| Decision Date | 2002-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153290940 | K021026 | 000 |
| 04546540395023 | K021026 | 000 |
| 04546540395016 | K021026 | 000 |
| 04546540395009 | K021026 | 000 |
| 04546540394996 | K021026 | 000 |
| 04546540394989 | K021026 | 000 |
| 04546540394972 | K021026 | 000 |