ISOLA(TM) SPINE SYSTEM - ILIAC SCREW— 510(k) K911528

Substantially Equivalent for Some Indications

Acromed Corp.

FDA 510(k) clearance K911528 for ISOLA(TM) SPINE SYSTEM - ILIAC SCREW, Substantially Equivalent for Some Indications on 1991-06-28. Applicant: Acromed Corp..

Clearance details

Applicant: Acromed Corp.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1991-04-04
Decision date: 1991-06-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.