Home / 510(k) Clearances / K951904

510(k) K951904

SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] by Synthes (Usa) — Product Code JDO

K951904 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]". The FDA issued a decision of Substantially Equivalent on Jul 17, 1995. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 17, 1995
Date Received
Apr 24, 1995
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 by Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (Dec 21, 2018)
  • K152239 — Zero-P Natural Plate System (Dec 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (Mar 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (Dec 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (Aug 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (Jul 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (Mar 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (Jan 21, 2011)

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (Apr 18, 2023)
  • K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V (Sep 29, 2022)
  • K210247 — OsteoCentric Integrated Hip Fastener System (Apr 30, 2021)
  • K193029 — CONQUEST FN (Feb 28, 2020)
  • K173826 — THP Hip Fracture Plating System (Feb 7, 2018)
  • K172785 — CONQUEST FN (Dec 22, 2017)
  • K152686 — CONQUEST FN (Mar 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (Apr 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (Aug 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (Apr 10, 2008)

FDA data resources