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

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..

Clearance details

Applicant: Genesis Orthopedics, Inc.
Product code: Code HTY
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 ↗

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.