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510(k) K191016

COPAL exchange G Hip and Knee Spacers by Heraeus Medical GmbH — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2019
Date Received
April 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Heraeus Medical GmbH

  • K241674 — OSTEOPAL® V (December 5, 2024)
  • K234028 — COPAL® exchange G hip spacer; COPAL® G+V (February 15, 2024)
  • K222570 — COPAL knee moulds (February 4, 2023)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • 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)
  • K190766 — PALACOS fast R+G (May 31, 2019)
  • K182260 — PALACOS MV (September 17, 2018)
  • K153737 — OSTEOPAL plus (April 22, 2016)

Other clearances for product code KWY

  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)
  • K183114 — Corin BiPolar-i (June 5, 2019)