The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for S2 Tibial Nail.
| Device ID | K022481 |
| 510k Number | K022481 |
| Device Name: | S2 TIBIAL 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 | 2002-07-29 |
| Decision Date | 2002-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540397133 | K022481 | 000 |
| 04546540396358 | K022481 | 000 |
| 04546540396389 | K022481 | 000 |
| 04546540396396 | K022481 | 000 |
| 04546540396426 | K022481 | 000 |
| 04546540396433 | K022481 | 000 |
| 04546540397041 | K022481 | 000 |
| 04546540397058 | K022481 | 000 |
| 04546540397089 | K022481 | 000 |
| 04546540397096 | K022481 | 000 |
| 04546540397126 | K022481 | 000 |
| 04546540396341 | K022481 | 000 |