The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Subfix Arthroereisis Implant, Models Sut0065, Sut0080, Sut0090, Sut0100, Sut0115.
| Device ID | K093820 |
| 510k Number | K093820 |
| Device Name: | SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252263531 | K093820 | 000 |
| 07613252263524 | K093820 | 000 |
| 07613252263517 | K093820 | 000 |
| 07613252263500 | K093820 | 000 |
| 07613252263494 | K093820 | 000 |