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 |