CAMELBACK HANDLE-K841969-LABELING— 510(k) K841970

Substantially Equivalent

Stainless Mfg., Inc.

FDA 510(k) clearance K841970 for CAMELBACK HANDLE-K841969-LABELING, Substantially Equivalent on 1984-06-19. Applicant: Stainless Mfg., Inc..

Clearance details

Applicant: Stainless Mfg., Inc.
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1984-05-14
Decision date: 1984-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.