The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Ankle Arthrodesis Nail.
| Device ID | K051590 |
| 510k Number | K051590 |
| Device Name: | T2 ANKLE ARTHRODESIS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540673459 | K051590 | 000 |
| 04546540673275 | K051590 | 000 |
| 04546540673282 | K051590 | 000 |
| 04546540673299 | K051590 | 000 |
| 04546540673305 | K051590 | 000 |
| 04546540673312 | K051590 | 000 |
| 04546540673336 | K051590 | 000 |
| 04546540673343 | K051590 | 000 |
| 04546540673350 | K051590 | 000 |
| 04546540673367 | K051590 | 000 |
| 04546540673374 | K051590 | 000 |
| 04546540673381 | K051590 | 000 |
| 04546540673398 | K051590 | 000 |
| 04546540673404 | K051590 | 000 |
| 04546540673411 | K051590 | 000 |
| 04546540673428 | K051590 | 000 |
| 04546540673435 | K051590 | 000 |
| 04546540673442 | K051590 | 000 |
| 04546540673213 | K051590 | 000 |