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510(k) K013954

LORENZ SELF DRILLING SCREWS by Walter Lorenz Surgical, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2002
Date Received
November 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
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)
  • K042516 — OTOMIMIX (November 8, 2004)
  • 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)

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