The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To Hoffmann Ii Micro External Fixation System.
| Device ID | K033476 |
| 510k Number | K033476 |
| Device Name: | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | KTT |
| Subsequent Product Code | JEC |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-03 |
| Decision Date | 2004-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540389954 | K033476 | 000 |
| 04546540389947 | K033476 | 000 |
| 04546540389930 | K033476 | 000 |
| 04546540389923 | K033476 | 000 |
| 04546540389916 | K033476 | 000 |
| 04546540389909 | K033476 | 000 |
| 04546540389893 | K033476 | 000 |