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FDA 510(k)

LEFORTE NEURO SYSTEM BONE PLATE

K-Number: K103778 · 2011-01-26

ApplicantJeil Medical Corporation
Decision Date2011-01-26
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEFORTE NEURO SYSTEM BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2011-01-26 under 510(k) number K103778. 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 LEFORTE NEURO SYSTEM BONE PLATE?

LEFORTE NEURO SYSTEM BONE PLATE is a medical device that received FDA 510(k) clearance on 2011-01-26. The listed applicant is Jeil Medical Corporation. The 510(k) number is K103778.

When did LEFORTE NEURO SYSTEM BONE PLATE receive FDA 510(k) clearance?

LEFORTE NEURO SYSTEM BONE PLATE received FDA 510(k) clearance on 2011-01-26, under 510(k) number K103778.

Who is the listed applicant for LEFORTE NEURO SYSTEM BONE PLATE?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEFORTE NEURO SYSTEM BONE PLATE?

The FDA product code for LEFORTE NEURO SYSTEM BONE PLATE 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

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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