FEMORAL CEMENT REMOVAL INSTRUMENT— 510(k) K840735

Name: FDA 510(k) clearance K840735
Creator: U.S. Food and Drug Administration
Published: 1984-05-14

Substantially Equivalent

Amtech Scientific, Inc.

FDA 510(k) clearance K840735 for FEMORAL CEMENT REMOVAL INSTRUMENT, Substantially Equivalent on 1984-05-14. Applicant: Amtech Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Amtech Scientific, Inc.
Product code: Code HWX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1984-02-21
Decision date: 1984-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWX

view all

K873067 — ACROMED BONE SCREW TAP SLEEVES1987-09-02

Adverse events under product code HWX

product code HWX

Malfunction: 559
Total: 559

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.