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510(k) K943378

IMPLEX CEMENT RESTRICTOR SYSTEM by Implex Corp. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1994
Date Received
July 13, 1994
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

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  • K032527 — HEDROCEL VERTEBRAL BODY REPLACEMENT (October 31, 2003)
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  • K031449 — MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOU (September 23, 2003)

Other clearances for product code LZN

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  • 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)
  • 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)