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510(k) K911717

ADG INTRAMEDULLARY BONE PLUG - VENTED by American Design Group, Inc. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1991
Date Received
April 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement Obturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by American Design Group, Inc.

  • K902615 — ADG BONE PLUG (September 11, 1990)
  • K890722 — ADG BONE BIOPSY SYSTEM (September 21, 1989)

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  • K023680 — BIOBUCK CEMENT RESTRICTOR (November 19, 2002)
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  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)