The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Threaded Anchor (modification).
Device ID | K961094 |
510k Number | K961094 |
Device Name: | MITEK THREADED ANCHOR (MODIFICATION) |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Contact | Edward F Kent |
Correspondent | Edward F Kent MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-14 |
Decision Date | 1996-10-03 |
Summary: | summary |