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FDA 510(k)

KLS Martin Pure Pectus System

K-Number: K250988 · 2025-12-11

ApplicantKLS-Martin L.P.
Decision Date2025-12-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLS Martin Pure Pectus 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 2025-12-11 under 510(k) number K250988. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Pure Pectus System?

KLS Martin Pure Pectus System is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is KLS-Martin L.P.. The 510(k) number is K250988.

When did KLS Martin Pure Pectus System receive FDA 510(k) clearance?

KLS Martin Pure Pectus System received FDA 510(k) clearance on 2025-12-11, under 510(k) number K250988.

Who is the listed applicant for KLS Martin Pure Pectus 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 Pure Pectus System?

The FDA product code for KLS Martin Pure Pectus System is HRS.

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 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 SystemK233721KLS Martin Drill-Free MMF Screw

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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