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510(k) K962224

SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS by Intermedics Orthopedics — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1996
Date Received
June 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
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)

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