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FDA 510(k)

OssBuilder System

K-Number: K181854 · 2019-05-07

ApplicantOsstem Implant Co., Ltd.
Decision Date2019-05-07
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OssBuilder System is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K181854. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OssBuilder System?

OssBuilder System is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K181854.

When did OssBuilder System receive FDA 510(k) clearance?

OssBuilder System received FDA 510(k) clearance on 2019-05-07, under 510(k) number K181854.

Who is the listed applicant for OssBuilder System?

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

What is the FDA product code for OssBuilder System?

The FDA product code for OssBuilder System is DZL.

Other records listing Osstem Implant Co., Ltd. as applicant

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Related Devices (Code: DZL)

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.

K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbHK233721KLS Martin Drill-Free MMF ScrewKLS-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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