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510(k) K911717

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

K911717 is an FDA 510(k) premarket notification submitted by American Design Group, Inc. for the device "ADG INTRAMEDULLARY BONE PLUG - VENTED". The FDA issued a decision of Substantially Equivalent on September 4, 1991. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. American Design Group, Inc. has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code LZN

  • K220838 — Artisan Bone Plug, Universal Cement Restrictor (May 20, 2022)
  • K061824 — TORNIER CEMENT RESTRICTOR (September 14, 2006)
  • K032685 — CEMSTOP CEMENT RESTRICTOR (November 26, 2003)
  • K023680 — BIOBUCK CEMENT RESTRICTOR (November 19, 2002)
  • K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (September 19, 2001)
  • K010840 — SYNPLUG (April 20, 2001)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)

FDA data resources