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510(k) K890450

INTERMEDICS APR(TM) II FEMORAL COMPONENT by Intermedics Orthopedics — Product Code JDJ

K890450 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "INTERMEDICS APR(TM) II FEMORAL COMPONENT". The FDA issued a decision of SN on August 9, 1989. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 9, 1989
Date Received
January 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
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 JDJ

  • K972760 — LINK, ACETABULAR REVISION MESH CUP (October 22, 1997)
  • K970957 — OSTEONICS RESTORATION ACETABULAR RING (June 3, 1997)
  • K963940 — EXETER MESH (February 13, 1997)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)

FDA data resources