The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Shoulder Guide And Models, Materialise Surgicase Shoulder Planner, Materialise Shoulder Planner, Surgicase Shoulder Planner, Surgicase Planner.
Device ID | K193560 |
510k Number | K193560 |
Device Name: | Materialise Shoulder Guide And Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner |
Classification | Shoulder Arthroplasty Implantation System |
Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
Contact | Veerle Vanderheyden |
Correspondent | Veerle Vanderheyden Materialise NV Technologielaan 15 Leuven, BE 3001 |
Product Code | QHE |
Subsequent Product Code | KWS |
Subsequent Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-03-20 |