TYPE 316L COTTER WIRE— 510(k) K864375

Substantially Equivalent for Some Indications

Winn Hirsch & Assoc.

FDA 510(k) clearance K864375 for TYPE 316L COTTER WIRE, Substantially Equivalent for Some Indications on 1987-05-20. Applicant: Winn Hirsch & Assoc..

Clearance details

Applicant: Winn Hirsch & Assoc.
Product code: Code LRN
Advisory panel: Orthopedic
Date received: 1986-11-05
Decision date: 1987-05-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Plainview, NY, US

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Adverse events under product code LRN

product code LRN

Injury: 185
Total: 185

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.