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510(k) K222570

COPAL knee moulds by Heraeus Medical GmbH — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2023
Date Received
August 23, 2022
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 Heraeus Medical GmbH

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  • K213812 — PALACOS MV pro (February 2, 2022)
  • K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (July 9, 2021)
  • K202475 — PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (November 23, 2020)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K190766 — PALACOS fast R+G (May 31, 2019)
  • K182260 — PALACOS MV (September 17, 2018)
  • K153737 — OSTEOPAL plus (April 22, 2016)

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