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510(k) K013107

BIOABSORBABLE INTERFERENCE SCREW MEGAFIX by Karl Storz Endoscopy — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2002
Date Received
September 17, 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 Karl Storz Endoscopy

  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K030848 — PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (June 2, 2003)
  • K030009 — KSEA POWERSHAVER SYSTEM S2 (April 2, 2003)
  • K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR (February 21, 2003)
  • K023187 — KSEA SPINOSCOPE (December 2, 2002)
  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
  • K021776 — KSEA QUADRO SWITCH (August 15, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)
  • K004037 — X-RAY SYSTEM XR-MX (February 2, 2001)

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