The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffman Xpress Line Extension.
Device ID | K092834 |
510k Number | K092834 |
Device Name: | HOFFMAN XPRESS LINE EXTENSION |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Melissa A Matarese |
Correspondent | Melissa A Matarese HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-15 |
Decision Date | 2009-10-08 |
Summary: | summary |