ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION— 510(k) K922766

Unknown

Acufex Microsurgical, Inc.

FDA 510(k) clearance K922766 for ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION, Unknown on 1993-07-09. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1992-06-02
Decision date: 1993-07-09
Decision: Unknown
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.