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FDA 510(k)

ORLUS MINI SCREW

K-Number: K082838 · 2008-11-25

ApplicantOrtholution Co., Ltd.
Decision Date2008-11-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORLUS MINI SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ortholution Co., Ltd.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082838. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORLUS MINI SCREW?

ORLUS MINI SCREW is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Ortholution Co., Ltd.. The 510(k) number is K082838.

When did ORLUS MINI SCREW receive FDA 510(k) clearance?

ORLUS MINI SCREW received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082838.

Who is the listed applicant for ORLUS MINI SCREW?

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

What is the FDA product code for ORLUS MINI SCREW?

The FDA product code for ORLUS MINI SCREW is DZE.

Related Clinical Trials

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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Other records listing Ortholution 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.

K052968MODIFICATION TO: ORLUS MINI SCREWK050568ORLUS MINI SCREW

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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