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

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..

Clearance details

Applicant
KLS-Martin L.P.
Product code
Code PBF
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jacksonville, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code PBF

product code PBF
Injury
180
Total
180

Source: openFDA MAUDE database, through . 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.