SONGER WIRING SYSTEM— 510(k) K892651

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K892651 for SONGER WIRING SYSTEM, Substantially Equivalent on 1989-07-25. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code LRN
Advisory panel: Orthopedic
Date received: 1989-04-13
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.