The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Memometal Intra-medullary Bone Fastener.
| Device ID | K112197 |
| 510k Number | K112197 |
| Device Name: | MEMOMETAL INTRA-MEDULLARY BONE FASTENER |
| Classification | Pin, Fixation, Smooth |
| Applicant | MEMOMETAL TECHNOLOGIES CAMPUS DE KER LANN RUE BLAISE PASCAL Bruz, FR F35170 |
| Contact | Gilles Audic |
| Correspondent | Gilles Audic MEMOMETAL TECHNOLOGIES CAMPUS DE KER LANN RUE BLAISE PASCAL Bruz, FR F35170 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2011-11-17 |
| Summary: | summary |