The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for S2 Femoral Nail.
| Device ID | K022461 |
| 510k Number | K022461 |
| Device Name: | S2 FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS 59 ROUTE 17 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 | 2002-07-26 |
| Decision Date | 2002-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540401182 | K022461 | 000 |
| 04546540399465 | K022461 | 000 |
| 04546540399472 | K022461 | 000 |
| 04546540399489 | K022461 | 000 |
| 04546540399496 | K022461 | 000 |
| 04546540399502 | K022461 | 000 |
| 04546540399519 | K022461 | 000 |
| 04546540399526 | K022461 | 000 |
| 04546540399533 | K022461 | 000 |
| 04546540399540 | K022461 | 000 |
| 04546540399557 | K022461 | 000 |
| 04546540399564 | K022461 | 000 |
| 04546540399588 | K022461 | 000 |
| 04546540399595 | K022461 | 000 |
| 04546540399601 | K022461 | 000 |
| 04546540399618 | K022461 | 000 |
| 04546540399625 | K022461 | 000 |
| 04546540399458 | K022461 | 000 |