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510(k) K933077

EXETER INTRAMEDULLARY BONE PLUG by Howmedica Corp. — Product Code LZN

K933077 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "EXETER INTRAMEDULLARY BONE PLUG". The FDA issued a decision of SN on May 16, 1995. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 16, 1995
Date Received
June 23, 1993
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 Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 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)
  • 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