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510(k) K833468

BDH UNIVERSAL HIP SYSTEM SURGEON by Carbomedics, Inc. — Product Code JDG

K833468 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "BDH UNIVERSAL HIP SYSTEM SURGEON". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
October 6, 1983
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 Carbomedics, Inc.

  • K970375 — ANNULOFLO SYSTEM (July 25, 1997)
  • K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (February 19, 1997)
  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)
  • K960706 — VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT (April 25, 1996)
  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K955588 — VASCUTEK GRAFT SIZER SET (March 7, 1996)
  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)
  • K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (July 6, 1994)

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