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510(k) K882349

MALLET, SURGICAL by Treace Medical, Inc. — Product Code HXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
June 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mallet
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)
  • K870763 — SUPER SCISSORS (March 18, 1987)

Other clearances for product code HXL

  • K872209 — ARTHROPLASTY MALLET (June 23, 1987)
  • K871195 — MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. (April 6, 1987)