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510(k) K153737

OSTEOPAL plus by Heraeus Medical GmbH — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2016
Date Received
December 28, 2015
Clearance Type
Special
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

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  • 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)
  • 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)

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)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)