STAXX XD SYSTEM— 510(k) K090315

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K090315 for STAXX XD SYSTEM, Substantially Equivalent on 2009-09-03. Applicant: Spine Wave, Inc..

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2009-02-09
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.