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FDA 510(k)

I-GEN

K-Number: K131289 · 2013-09-25

ApplicantMegagen Implant Co., Ltd.
Decision Date2013-09-25
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-GEN is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2013-09-25 under 510(k) number K131289. 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 I-GEN?

I-GEN is a medical device that received FDA 510(k) clearance on 2013-09-25. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K131289.

When did I-GEN receive FDA 510(k) clearance?

I-GEN received FDA 510(k) clearance on 2013-09-25, under 510(k) number K131289.

Who is the listed applicant for I-GEN?

The FDA 510(k) record lists Megagen Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-GEN?

The FDA product code for I-GEN is JEY.

Other records listing Megagen Implant Co., Ltd. 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.

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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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