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510(k) K210247

OsteoCentric Integrated Hip Fastener System by Osteocentric Technologies D.B.A. Osteocentric Trauma — Product Code JDO

K210247 is an FDA 510(k) premarket notification submitted by Osteocentric Technologies D.B.A. Osteocentric Trauma for the device "OsteoCentric Integrated Hip Fastener System". The FDA issued a decision of Substantially Equivalent on April 30, 2021. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2021
Date Received
January 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V (September 29, 2022)
  • K193029 — CONQUEST FN (February 28, 2020)
  • K173826 — THP Hip Fracture Plating System (February 7, 2018)
  • K172785 — CONQUEST FN (December 22, 2017)
  • K152686 — CONQUEST FN (March 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (April 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (August 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (April 10, 2008)
  • K983814 — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (January 14, 1999)

FDA data resources