ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS— 510(k) K941364

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K941364 for ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS, Substantially Equivalent on 1994-05-16. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-03-21
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.