The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Memometal Anchorage Bone Plate System, Models Plss/plsl, Plp10/plp20/plp30/plp40/plp50.
| Device ID | K083447 |
| 510k Number | K083447 |
| Device Name: | MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-02-06 |
| Summary: | summary |