ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK— 510(k) K905184

Substantially Equivalent for Some Indications

Acromed Corp.

FDA 510(k) clearance K905184 for ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK, Substantially Equivalent for Some Indications on 1991-02-15. Applicant: Acromed Corp..

Clearance details

Applicant: Acromed Corp.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1990-11-19
Decision date: 1991-02-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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.