MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM— 510(k) K970896

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K970896 for MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM, Substantially Equivalent on 1997-06-09. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1997-03-11
Decision date: 1997-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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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.