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510(k) K950998

MODUILAR UNIPOLAR by Intermedics Orthopedics — Product Code KXA

K950998 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "MODUILAR UNIPOLAR". The FDA issued a decision of Substantially Equivalent on April 13, 1995. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1995
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
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)
  • K963155 — INTERMOORE FRACTURE HIP STEM (MODIFY) (October 1, 1996)
  • K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (September 3, 1996)

Other clearances for product code KXA

  • K201219 — Biocore9 Femoral Head Resurfacing Component (January 19, 2021)
  • K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD (April 15, 2010)
  • K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT (December 12, 2008)
  • K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (June 29, 2007)
  • K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (April 26, 2007)
  • K062960 — CONSERVE FEMORAL RESURFACING COMPONENT (December 1, 2006)
  • K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT (May 18, 2005)
  • K032659 — DEPUY ASR RESURFACING FEMORAL HEADS (December 4, 2003)
  • K023188 — PRESS-FIT HEAD RESURFACING DEVICE (December 11, 2002)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)

FDA data resources