KLS Martin Pure Pectus System
K-Number: K221938 · 2023-03-28
ApplicantKLS Martin L.P.
Decision Date2023-03-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
KLS Martin Pure Pectus System is a medical device manufactured by KLS Martin L.P.. It received FDA 510(k) clearance on 2023-03-28 under approval number K221938. 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 2023-03-28. It is manufactured by KLS Martin L.P.. The 510(k) number is K221938.
When was KLS Martin Pure Pectus System approved by the FDA?
KLS Martin Pure Pectus System received FDA 510(k) clearance on 2023-03-28, under approval number K221938.
What company makes KLS Martin Pure Pectus System?
KLS Martin Pure Pectus System is manufactured by KLS Martin L.P..
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 Devices by KLS Martin L.P.
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
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.