510(k) K982900— PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW

Substantially Equivalent

Depuy, Inc.

Clearance details

Applicant: Depuy, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1998-08-17
Decision date: 1998-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.