Home / 510(k) Clearances / K212729

510(k) K212729

Bone Cement-Normal Viscosity by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2022
Date Received
August 27, 2021
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 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)
  • 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)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)