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510(k) K211883

QUANTUM® Patient Specific Instrumentation (PSI) System by In2bones Sas — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2021
Date Received
June 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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