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510(k) K821252

HOFFMAN UNIVERSAL FOOT SUPPORT by Howmedica Corp. — Product Code KQZ

K821252 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "HOFFMAN UNIVERSAL FOOT SUPPORT". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1982
Date Received
April 30, 1982
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 by Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

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)
  • K802869 — BACKTRAC 90-90 TRACTION (December 11, 1980)
  • K781754 — SPLINT, HOAKE INFLATABLE AIR (November 8, 1978)

FDA data resources