The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Memometal Implants (k-snap & Ti-fuse).
Device ID | K102072 |
510k Number | K102072 |
Device Name: | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) |
Classification | Pin, Fixation, Smooth |
Applicant | MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR 35170 |
Contact | Gilles Audic |
Correspondent | Gilles Audic MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR 35170 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-23 |
Decision Date | 2010-11-03 |
Summary: | summary |