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510(k) K202458

BonOs Inject, Pedicle screw kits, Cement pusher by Osartis GmbH — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2021
Date Received
August 27, 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 Osartis GmbH

  • K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (November 20, 2024)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)
  • K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (March 19, 2021)
  • K192394 — Hi-Fatigue Bone Cement (December 2, 2019)
  • K192379 — Hi-Fatigue G Bone Cement (November 27, 2019)

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)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)
  • K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (March 19, 2021)