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 |