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 |