MITEK BTB ABSORBABLE (PLA) CROSS PIN— 510(k) K974291

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K974291 for MITEK BTB ABSORBABLE (PLA) CROSS PIN, Substantially Equivalent on 1998-03-05. Applicant: Mitek Products.

Clearance details

Applicant: Mitek Products
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1997-11-14
Decision date: 1998-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.