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510(k) K942906

AGEE-WRISTJACK PRE-DRILL KIT by Hand Biomechanics Lab, Inc. — Product Code HTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
June 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K930339 — REAMER BIT (August 6, 1993)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K841629 — DRILL BIT (August 27, 1984)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)