The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To T2 Proximal Humeral Nail.
| Device ID | K043404 |
| 510k Number | K043404 |
| Device Name: | MODIFICATION TO T2 PROXIMAL HUMERAL 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2004-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540437174 | K043404 | 000 |
| 04546540437099 | K043404 | 000 |
| 04546540437105 | K043404 | 000 |
| 04546540437112 | K043404 | 000 |
| 04546540437129 | K043404 | 000 |
| 04546540437136 | K043404 | 000 |
| 04546540437143 | K043404 | 000 |
| 04546540437150 | K043404 | 000 |
| 04546540437167 | K043404 | 000 |
| 04546540437082 | K043404 | 000 |