Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KLS Martin Individual Patient Solutions (IPS) Planning System

K-Number: K182789 · 2019-03-11

Decision Date2019-03-11
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Individual Patient Solutions (IPS) Planning System is a medical device manufactured by KLS-Martin L.P.. It received FDA 510(k) clearance on 2019-03-11 under approval number K182789. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS Martin Individual Patient Solutions (IPS) Planning System is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by KLS-Martin L.P.. The 510(k) number is K182789.

When was KLS Martin Individual Patient Solutions (IPS) Planning System approved by the FDA?

KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance on 2019-03-11, under approval number K182789.

What company makes KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS Martin Individual Patient Solutions (IPS) Planning System is manufactured by KLS-Martin L.P..

What is the FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System?

The FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System is DZJ.

Related Clinical Trials

Related PubMed Literature

Other Devices by KLS-Martin L.P.

View all 21 devices →

Related Devices (Code: DZJ)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.