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510(k) K983036

SINGLE AXLE TOTAL ELBOW by Biomet, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
August 31, 1998
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

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  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
  • K090473 — DISCOVERY ELBOW - X-SMALL (March 25, 2009)
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  • K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (December 9, 2005)
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  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)