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510(k) K870217

FEMORAL CEMENT REMOVAL INSTRUMENTS by Kenneth J. Hoek, M.D., Inc. — Product Code HTW

K870217 is an FDA 510(k) premarket notification submitted by Kenneth J. Hoek, M.D., Inc. for the device "FEMORAL CEMENT REMOVAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1987
Date Received
January 21, 1987
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

Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • 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)

FDA data resources