The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Arthrodesis Nail System.
| Device ID | K020384 |
| 510k Number | K020384 |
| Device Name: | T2 ARTHRODESIS NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | William J Cymbaluk |
| Correspondent | William J Cymbaluk HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153297277 | K020384 | 000 |
| 07613153297482 | K020384 | 000 |
| 07613153297505 | K020384 | 000 |
| 07613153297529 | K020384 | 000 |
| 07613153297543 | K020384 | 000 |
| 07613153297567 | K020384 | 000 |
| 07613153297581 | K020384 | 000 |
| 07613153297604 | K020384 | 000 |
| 07613153297628 | K020384 | 000 |
| 07613153297468 | K020384 | 000 |
| 07613153297444 | K020384 | 000 |
| 07613153297420 | K020384 | 000 |
| 07613153297284 | K020384 | 000 |
| 07613153297291 | K020384 | 000 |
| 07613153297307 | K020384 | 000 |
| 07613153297321 | K020384 | 000 |
| 07613153297345 | K020384 | 000 |
| 07613153297369 | K020384 | 000 |
| 07613153297383 | K020384 | 000 |
| 07613153297406 | K020384 | 000 |
| 07613153297642 | K020384 | 000 |
| 07613153297666 | K020384 | 000 |
| 07613153297925 | K020384 | 000 |
| 07613153297949 | K020384 | 000 |
| 07613153297963 | K020384 | 000 |
| 07613153297987 | K020384 | 000 |
| 07613153298007 | K020384 | 000 |
| 07613153298021 | K020384 | 000 |
| 07613153298045 | K020384 | 000 |
| 07613153298069 | K020384 | 000 |
| 07613153297901 | K020384 | 000 |
| 07613153297888 | K020384 | 000 |
| 07613153297857 | K020384 | 000 |
| 07613153297697 | K020384 | 000 |
| 07613153297703 | K020384 | 000 |
| 07613153297734 | K020384 | 000 |
| 07613153297758 | K020384 | 000 |
| 07613153297772 | K020384 | 000 |
| 07613153297796 | K020384 | 000 |
| 07613153297819 | K020384 | 000 |
| 07613153297833 | K020384 | 000 |
| 07613153298083 | K020384 | 000 |