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510(k) K023680

BIOBUCK CEMENT RESTRICTOR by Smith & Nephew, Inc. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
November 1, 2002
Clearance Type
Special
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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Other clearances for product code LZN

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  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)
  • K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (May 9, 1997)