RETRACTORS— 510(k) K890158

Clearance details

Applicant

Dhason Brothers, Inc.

Product code

Code LXH

Device class

Class 1

Regulation

21 CFR 888.4540

Advisory panel

Orthopedic

Date received

1989-01-09

Decision date

1989-02-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hyattsville, MD, US

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• K140414 — IMBIBE NEEDLE2014-04-01
• K101609 — SELF RETAINING SOFT TISSUE RETRACTOR2010-12-09
• K001507 — MICROPERFORATION INSTRUMENT2000-06-14
• K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM1996-01-22

• K890156 — IMPACTOR FOR FEMORAL HEAD1989-02-13
• K890157 — FORCEPS1989-02-13
• K890160 — GOUGES FOR FEMORAL HEADS1989-02-13
• K890161 — THOMPSON TYPE RASP W/TOMMY BAR1989-02-13
• K890162 — EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD1989-02-13

Death

11

Injury

2,218

Malfunction

31,318

Total

33,547

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →