The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Memometal Intra-medullary Bone Fastener, Models Smart Toe / X-fuse.
Device ID | K070598 |
510k Number | K070598 |
Device Name: | MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE |
Classification | Pin, Fixation, Smooth |
Applicant | MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR F35170 |
Contact | Gilles Audic |
Correspondent | Gilles Audic MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR F35170 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-02 |
Decision Date | 2007-07-26 |
Summary: | summary |