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510(k) K202475

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G by Heraeus Medical GmbH — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2020
Date Received
August 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
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)
  • 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)

Other clearances for product code LOD

  • K250760 — SPECTRUM GV Bone Cement (April 2, 2025)
  • K241674 — OSTEOPAL® V (December 5, 2024)
  • K231556 — SPECTRUM® GV Bone Cement (December 20, 2023)
  • K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV (January 9, 2023)
  • K212729 — Bone Cement-Normal Viscosity (May 31, 2022)
  • K211869 — OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate ( (May 19, 2022)
  • K213812 — PALACOS MV pro (February 2, 2022)
  • K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (July 9, 2021)
  • K202458 — BonOs Inject, Pedicle screw kits, Cement pusher (May 18, 2021)
  • K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (March 19, 2021)