The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Minilok Quickanchor Plus.
Device ID | K030995 |
510k Number | K030995 |
Device Name: | MINILOK QUICKANCHOR PLUS |
Classification | Screw, Fixation, Bone |
Applicant | MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
Contact | Ruth C Forstadt |
Correspondent | Ruth C Forstadt MITEK WORLDWIDE 249 VANDERBILT AVE. 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 | 2003-03-31 |
Decision Date | 2003-06-26 |
Summary: | summary |