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510(k) K042516

OTOMIMIX by Walter Lorenz Surgical, Inc. — Product Code NEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2004
Date Received
September 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Ear, Nose And Throat
Device Class
Class II
Regulation Number
872.3275
Review Panel
EN
Submission Type

Other clearances by Walter Lorenz Surgical, Inc.

  • K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM (February 9, 2007)
  • K063052 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (January 12, 2007)
  • K063506 — LORENZ STERNAL CLOSURE SYSTEM (December 18, 2006)
  • K062842 — TWIST DRILL (December 4, 2006)
  • K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITAN (June 6, 2006)
  • K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (May 14, 2004)
  • K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (May 13, 2004)
  • K040983 — LORENZ SELF-DRILLING IMF SCREW (May 5, 2004)
  • K033740 — LORENZ STERNAL CLOSURE SYSTEM (December 15, 2003)
  • K032228 — LORENZ 2.4 SELF DRILLING SCREWS (August 11, 2003)

Other clearances for product code NEA

  • K140644 — PROCEM (June 19, 2014)
  • K080032 — ENVOYCEM, MODEL 1640 (February 28, 2008)
  • K060750 — STRYKER INJECTABLE CEMENT (April 19, 2006)
  • K011338 — OTO-CEM (September 13, 2001)
  • K003567 — SERENOCEM, MODEL BC 010 (February 12, 2001)