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FDA 510(k)

KLS Martin Individual Patient Solutions (IPS) Planning System

K-Number: K182889 · 2019-07-26

ApplicantKLS-Martin L.P.
Decision Date2019-07-26
Product CodePPT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Individual Patient Solutions (IPS) Planning System is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K182889. The device is classified under product code PPT. It was reviewed by the NE 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 2019-07-26. The listed applicant is KLS-Martin L.P.. The 510(k) number is K182889.

When did KLS Martin Individual Patient Solutions (IPS) Planning System receive FDA 510(k) clearance?

KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K182889.

Who is the listed applicant for KLS Martin Individual Patient Solutions (IPS) Planning System?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

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 PPT.

Other records listing KLS-Martin L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEK250620KLS Martin Ixos System

View all 32 devices →

Related Devices (Code: PPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NVK201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.K151285VSP Cranial System3D Systems, Inc.

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.

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