K954246

Substantially Equivalent for Some Indications

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW

Applicant: Acufex Microsurgical, Inc.
Product code: HWC
Advisory panel: Orthopedic
Date received: 1995-09-11
Decision date: 1996-02-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mansfield, MA, US

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.