GO UNIVERSALK-WIRE FLUTED DRILL— 510(k) K954543

Name: FDA 510(k) clearance K954543
Creator: U.S. Food and Drug Administration
Published: 1995-12-08

Substantially Equivalent for Some Indications

Genesis Orthopedics, Inc.

FDA 510(k) clearance K954543 for GO UNIVERSALK-WIRE FLUTED DRILL, Substantially Equivalent for Some Indications on 1995-12-08. Applicant: Genesis Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Genesis Orthopedics, Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1995-09-28
Decision date: 1995-12-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.