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FDA 510(k)

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM

K-Number: K950045 · 1995-03-23

ApplicantKarl Leibinger GmbH U. Co. KG
Decision Date1995-03-23
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Karl Leibinger GmbH U. Co. KG. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K950045. 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 MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM?

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Karl Leibinger GmbH U. Co. KG. The 510(k) number is K950045.

When did KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950045.

Who is the listed applicant for KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM?

The FDA 510(k) record lists Karl Leibinger GmbH U. Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM?

The FDA product code for KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM is JEY.

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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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.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 OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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