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510(k) K970567

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS by Intermedics Orthopedics — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1997
Date Received
February 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
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)
  • 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)
  • K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (August 29, 1996)

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