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510(k) K970779

OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS by Osteonics Corp. — Product Code LZN

K970779 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS". The FDA issued a decision of Substantially Equivalent on May 9, 1997. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
March 4, 1997
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 Osteonics Corp.

  • K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY (April 6, 2000)
  • K980070 — OSTEONICS HA-COATED DEVICES (July 23, 1999)
  • K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (April 30, 1999)
  • K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (March 25, 1999)
  • K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (February 24, 1999)
  • K990203 — OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (February 18, 1999)
  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
  • K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (December 18, 1998)
  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)

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)
  • 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)

FDA data resources