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510(k) K915391

FPC HIP STEM COMPONENT by Implantology Corp. — Product Code JDG

K915391 is an FDA 510(k) premarket notification submitted by Implantology Corp. for the device "FPC HIP STEM COMPONENT". The FDA issued a decision of Substantially Equivalent on April 30, 1993. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Implantology Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1993
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Implantology Corp.

  • K934729 — UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED (July 22, 1994)
  • K915529 — FPC/SFPC/RFPC ACETABULAR COMPONENT (July 13, 1993)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • K915527 — CPS ACETABULAR COMPONENT (June 24, 1993)
  • K915385 — PPC HIP STEM COMPONENT (May 17, 1993)
  • K924099 — UFC HIP STEM COMPONENT (April 30, 1993)
  • K915798 — PSK POSTERIOR STABILIZED TOATAL KNEE (March 4, 1993)
  • K915584 — CRK CONDYLAR RESURFACING TOTAL KNEE (February 12, 1993)

Other clearances for product code JDG

  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)

FDA data resources