ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES— 510(k) K922167

Substantially Equivalent

Alphatec Mfg., Inc.

FDA 510(k) clearance K922167 for ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES, Substantially Equivalent on 1992-08-06. Applicant: Alphatec Mfg., Inc..

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1992-05-08
Decision date: 1992-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.