KLS Martin Orthopedic Implants - MR Conditional
K-Number: K241018 · 2024-07-12
ApplicantKLS-Martin L.P.
Decision Date2024-07-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
KLS Martin Orthopedic Implants - MR Conditional is a medical device manufactured by KLS-Martin L.P.. It received FDA 510(k) clearance on 2024-07-12 under approval number K241018. 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 Orthopedic Implants - MR Conditional?
KLS Martin Orthopedic Implants - MR Conditional is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by KLS-Martin L.P.. The 510(k) number is K241018.
When was KLS Martin Orthopedic Implants - MR Conditional approved by the FDA?
KLS Martin Orthopedic Implants - MR Conditional received FDA 510(k) clearance on 2024-07-12, under approval number K241018.
What company makes KLS Martin Orthopedic Implants - MR Conditional?
KLS Martin Orthopedic Implants - MR Conditional is manufactured by KLS-Martin L.P..
What is the FDA product code for KLS Martin Orthopedic Implants - MR Conditional?
The FDA product code for KLS Martin Orthopedic Implants - MR Conditional is HRS.
Related Clinical Trials
Related PubMed Literature
PMID: 41388920
Balancing Innovation and the Safe Introduction of Orthopedic Arthroplasty Implants to Market: The Ever-Evolving Regulatory Environment in Australia.
Journal of orthopaedic research : official publication of the Orthopaedic Research Society (2026)
PMID: 40528079
The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey.
Therapeutic innovation & regulatory science (2025)
Other Devices by KLS-Martin L.P.
K153482KLS Martin Thoracic Plating System
K181241KLS Martin Individual Patient Solutions (IPS) Planning System
K180962KLS Martin Individual Patient Solutions
K191028KLS Martin Individual Patient Solutions
K182889KLS Martin Individual Patient Solutions (IPS) Planning System
K182789KLS Martin Individual Patient Solutions (IPS) Planning System
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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.