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510(k) K181307

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow by Zimmer, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
May 17, 2018
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)
  • K153398 — Comprehensive SRS/Nexel Elbow (February 3, 2016)
  • K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter (April 23, 2015)
  • 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)