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510(k) K201023

iTotal® Identity Posterior Stabilized Knee Replacement System by Conformis, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2020
Date Received
April 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Conformis, Inc.

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  • K221104 — Actera™ hip system (August 4, 2022)
  • K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (July 26, 2022)
  • K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (May 10, 2022)
  • K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Im (November 10, 2021)

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