MODIFICATION TO ISOLA SPINAL SYSTEM— 510(k) K993030

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K993030 for MODIFICATION TO ISOLA SPINAL SYSTEM, Substantially Equivalent on 1999-12-29. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1999-09-07
Decision date: 1999-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.