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510(k) K053189

COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES by Zimmer, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2005
Date Received
November 15, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type

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Other clearances for product code JDC

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  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
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  • K060696 — ACCLAIM TOTAL ELBOW SYSTEM (April 14, 2006)
  • K051975 — POROUS COATED DISCOVERY ELBOW (September 6, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
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