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510(k) K193312

UNIKO PointCloud™ Knee Instruments by Unik Orthopedics, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2020
Date Received
November 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Unik Orthopedics, Inc.

  • K240327 — UNIKO PointCloud™ Knee Instruments (June 27, 2024)

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