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510(k) K802869

BACKTRAC 90-90 TRACTION by Backtrac — Product Code KQZ

K802869 is an FDA 510(k) premarket notification submitted by Backtrac for the device "BACKTRAC 90-90 TRACTION". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Non-Invasive
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type

Other clearances for product code KQZ

  • K884132 — TECNOL BUCKS TRACTION W/HEEL PROTECTOR (October 11, 1988)
  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)
  • K871900 — OVER DRAPE LEG HOLDER (June 16, 1987)
  • K871296 — T.E.D.(TM) TRACTION DEVICE (April 15, 1987)
  • K854270 — MURPHY ADJUSTABLE SPLINT (December 9, 1985)
  • K831002 — TPG 1000 (June 24, 1983)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823163 — UNIVERSAL BUCKS TRACTION (November 10, 1982)
  • K821252 — HOFFMAN UNIVERSAL FOOT SUPPORT (June 22, 1982)
  • K781754 — SPLINT, HOAKE INFLATABLE AIR (November 8, 1978)

FDA data resources