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510(k) K890156

IMPACTOR FOR FEMORAL HEAD by Dhason Brothers, Inc. — Product Code LXH

K890156 is an FDA 510(k) premarket notification submitted by Dhason Brothers, Inc. for the device "IMPACTOR FOR FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Dhason Brothers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1989
Date Received
January 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Dhason Brothers, Inc.

  • K890162 — EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD (February 13, 1989)
  • K890165 — FORCEPS-ORTHOPEDIC (February 13, 1989)
  • K890166 — RONGUER-ORTHOPEDIC (February 13, 1989)
  • K890158 — RETRACTORS (February 13, 1989)
  • K890163 — AUSTIN MOORE HALLOW CHISEL (February 13, 1989)
  • K890164 — HUDSON BRACE W/BURRS (February 13, 1989)
  • K890168 — RETRACTOR, SELF-RETAINING (February 13, 1989)
  • K890160 — GOUGES FOR FEMORAL HEADS (February 13, 1989)
  • K890161 — THOMPSON TYPE RASP W/TOMMY BAR (February 13, 1989)
  • K890157 — FORCEPS (February 13, 1989)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources