The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Femoral Nail.
| Device ID | K021744 |
| 510k Number | K021744 |
| Device Name: | T2 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 | 2002-05-28 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540369734 | K021744 | 000 |
| 04546540369437 | K021744 | 000 |
| 04546540369475 | K021744 | 000 |
| 04546540369482 | K021744 | 000 |
| 04546540369529 | K021744 | 000 |
| 04546540369536 | K021744 | 000 |
| 04546540369574 | K021744 | 000 |
| 04546540369581 | K021744 | 000 |
| 04546540369628 | K021744 | 000 |
| 04546540369635 | K021744 | 000 |
| 04546540369673 | K021744 | 000 |
| 04546540369680 | K021744 | 000 |
| 04546540369727 | K021744 | 000 |
| 04546540369420 | K021744 | 000 |