KLS Martin Individual Patient Solutions (IPS) Planning System— 510(k) K192979

Name: FDA 510(k) clearance K192979
Creator: U.S. Food and Drug Administration
Published: 2020-03-11

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K192979 for KLS Martin Individual Patient Solutions (IPS) Planning System, Substantially Equivalent on 2020-03-11. Applicant: KLS-Martin L.P.. Device class: 2.

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code PBF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-10-24
Decision date: 2020-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.