K952687

Substantially Equivalent for Some Indications

PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM

Applicant: ETHICON, Inc.
Product code: MAI
Advisory panel: Orthopedic
Date received: 1995-06-12
Decision date: 1996-02-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Somerville, NJ, 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.