Home / 510(k) Clearances / K254107

510(k) K254107

Refobacin Bone Cement R (110034355) by Biomet France — Product Code LOD

K254107 is an FDA 510(k) premarket notification submitted by Biomet France for the device "Refobacin Bone Cement R (110034355)". The FDA issued a decision of Substantially Equivalent on April 15, 2026. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
December 19, 2025
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)
  • 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)

FDA data resources