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510(k) K861915

SURGICAL HEAD SUPPORT by Treace Medical, Inc. — Product Code CCX

K861915 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "SURGICAL HEAD SUPPORT". The FDA issued a decision of Substantially Equivalent on May 30, 1986. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1986
Date Received
May 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Patient Position
Device Class
Class I
Regulation Number
868.6820
Review Panel
AN
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • 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)

Other clearances for product code CCX

  • K943837 — CHIN UP (October 14, 1994)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K934235 — SNIFF POSITION PILLOW (October 1, 1993)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K821838 — VARI-SUPPORT LOW BACK POSTURE PILLOW (July 20, 1982)
  • K810035 — PRENATAL SUPPORT PILLOW (January 23, 1981)
  • K801330 — ANSPACH LEG SUPPORT (June 26, 1980)

FDA data resources