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FDA 510(k)

KLS Martin Oral-Max Implants MR Conditional (bundled)

K-Number: K241314 · 2024-08-16

ApplicantKLS-Martin L.P.
Decision Date2024-08-16
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Oral-Max Implants MR Conditional (bundled) 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 2024-08-16 under 510(k) number K241314. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Oral-Max Implants MR Conditional (bundled)?

KLS Martin Oral-Max Implants MR Conditional (bundled) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is KLS-Martin L.P.. The 510(k) number is K241314.

When did KLS Martin Oral-Max Implants MR Conditional (bundled) receive FDA 510(k) clearance?

KLS Martin Oral-Max Implants MR Conditional (bundled) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K241314.

Who is the listed applicant for KLS Martin Oral-Max Implants MR Conditional (bundled)?

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 Oral-Max Implants MR Conditional (bundled)?

The FDA product code for KLS Martin Oral-Max Implants MR Conditional (bundled) is JEY.

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

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Related Devices (Code: JEY)

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.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK240651MRI UniversalStryker Leibinger GmbH & Co KGK233874tmCMF SolutionTechmah Cmf

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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