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510(k) K150501

Zimmer Nexel Total Elbow Ulnar Cement Diverter by Zimmer, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2015
Date Received
February 26, 2015
Clearance Type
Traditional
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

  • K181362 — TEMA Elbow System (February 16, 2019)
  • K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (January 28, 2019)
  • K153398 — Comprehensive SRS/Nexel Elbow (February 3, 2016)
  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
  • K090473 — DISCOVERY ELBOW - X-SMALL (March 25, 2009)
  • K060696 — ACCLAIM TOTAL ELBOW SYSTEM (April 14, 2006)
  • K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (December 9, 2005)
  • K051975 — POROUS COATED DISCOVERY ELBOW (September 6, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K040389 — COONRAD/MORREY ELBOW CEMENT RESTRICTOR (May 17, 2004)