CAPSURE(R) PS SYSTEM— 510(k) K111913

Name: FDA 510(k) clearance K111913
Creator: U.S. Food and Drug Administration
Published: 2011-08-31

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K111913 for CAPSURE(R) PS SYSTEM, Substantially Equivalent on 2011-08-31. Applicant: Spine Wave, Inc.. Device class: 2.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2011-07-06
Decision date: 2011-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.