MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME— 510(k) K874298

Substantially Equivalent

Engineered Orthopedic Technologies, Inc.

FDA 510(k) clearance K874298 for MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME, Substantially Equivalent on 1988-02-04. Applicant: Engineered Orthopedic Technologies, Inc..

Clearance details

Applicant: Engineered Orthopedic Technologies, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 1987-10-20
Decision date: 1988-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.