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510(k) K062553

SIMPLEX P BONE CEMENT by Stryker Orthopaedics — Product Code LOD

K062553 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "SIMPLEX P BONE CEMENT". The FDA issued a decision of Substantially Equivalent on January 8, 2007. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2007
Date Received
August 30, 2006
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 Stryker Orthopaedics

  • K211703 — Insignia Hip Stem (August 16, 2021)
  • K191414 — EXETER Centralizer, EXETER 2.5mm Plug (August 28, 2019)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K173849 — Triathlon Total Knee System (February 2, 2018)
  • K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (October 30, 2017)
  • K153345 — Stryker Orthopaedics Hip Systems Labeling Update (May 25, 2016)
  • K151264 — Restoration Anatomic Shell (August 10, 2015)
  • K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments (February 9, 2015)
  • K143393 — Triathlon Tritanium Cone Augments (January 13, 2015)
  • K142462 — Restoration Anatomic Shell (November 14, 2014)

Other clearances for product code LOD

  • K254107 — Refobacin Bone Cement R (110034355) (April 15, 2026)
  • 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)

FDA data resources