The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Femoral Nail System.
| Device ID | K014220 |
| 510k Number | K014220 |
| Device Name: | T2 FEMORAL NAIL SYSTEM |
| 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 | 2001-12-26 |
| Decision Date | 2002-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540202277 | K014220 | 000 |
| 04546540202116 | K014220 | 000 |
| 04546540202123 | K014220 | 000 |
| 04546540202130 | K014220 | 000 |
| 04546540202147 | K014220 | 000 |
| 04546540202154 | K014220 | 000 |
| 04546540202161 | K014220 | 000 |
| 04546540202178 | K014220 | 000 |
| 04546540202185 | K014220 | 000 |
| 04546540202192 | K014220 | 000 |
| 04546540202208 | K014220 | 000 |
| 04546540202215 | K014220 | 000 |
| 04546540202222 | K014220 | 000 |
| 04546540202239 | K014220 | 000 |
| 04546540202246 | K014220 | 000 |
| 04546540202253 | K014220 | 000 |
| 04546540202260 | K014220 | 000 |
| 04546540202109 | K014220 | 000 |