SPINESMITH CIMPLICITY SPINAL SYSTEM— 510(k) K080971

Substantially Equivalent

Spine Smith Partners L.P.

FDA 510(k) clearance K080971 for SPINESMITH CIMPLICITY SPINAL SYSTEM, Substantially Equivalent on 2008-07-02. Applicant: Spine Smith Partners L.P..

Clearance details

Applicant: Spine Smith Partners L.P.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2008-04-04
Decision date: 2008-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.