ACUFEX SMOOTH AND THREADED PINS— 510(k) K931836

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K931836 for ACUFEX SMOOTH AND THREADED PINS, Substantially Equivalent on 1994-06-28. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1993-04-13
Decision date: 1994-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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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.