The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Biocryl Rapide Interference Screw.
Device ID | K032717 |
510k Number | K032717 |
Device Name: | BIOCRYL RAPIDE INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
Contact | Karen K Sylvia |
Correspondent | Karen K Sylvia MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-02 |
Decision Date | 2004-03-31 |
Summary: | summary |