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510(k) K212569

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner by Materialise NV — Product Code QHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2022
Date Received
August 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

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