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510(k) K802598

CARBIDE CUTTING INSTRUMENT/INTRAARTICU by The Anspach Effort, Inc. — Product Code HTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1980
Date Received
October 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burr, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (December 31, 2013)
  • K113476 — ANSPACH DISSECTION TOOLS (December 16, 2011)
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  • K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, E (April 30, 2008)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)

Other clearances for product code HTT

  • K862529 — HALL STERILE BUR (July 15, 1986)
  • K821695 — MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER (July 20, 1982)
  • K760236 — BUR, SURGICAL CARBIDE (July 26, 1976)