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510(k) K963155

INTERMOORE FRACTURE HIP STEM (MODIFY) by Intermedics Orthopedics — Product Code LWJ

K963155 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "INTERMOORE FRACTURE HIP STEM (MODIFY)". The FDA issued a decision of Substantially Equivalent on October 1, 1996. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1996
Date Received
August 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Intermedics Orthopedics

  • K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI (July 3, 1997)
  • K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS (April 30, 1997)
  • K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM (April 8, 1997)
  • K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (February 27, 1997)
  • K964357 — NATURAL-HIP SYSTEM COCR STEM (January 27, 1997)
  • K964350 — MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA (January 16, 1997)
  • K962190 — PATELLOFEMORAL JOINT PROSTHESIS (October 28, 1996)
  • K963266 — NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED (October 15, 1996)
  • K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (September 3, 1996)
  • K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (August 29, 1996)

Other clearances for product code LWJ

  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)

FDA data resources