Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bone Screw

K-Number: K251569 · 2025-08-13

ApplicantOsstem Implant Co., Ltd.
Decision Date2025-08-13
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bone Screw 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 2025-08-13 under 510(k) number K251569. 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 Bone Screw?

Bone Screw is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K251569.

When did Bone Screw receive FDA 510(k) clearance?

Bone Screw received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251569.

Who is the listed applicant for Bone Screw?

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 Bone Screw?

The FDA product code for Bone Screw is DZL.

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.

NCT04002518MDR - Biomet Cannulated ScrewsACTIVE_NOT_RECRUITING

Other records listing Osstem 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.

K251434Healing Abutment SystemK242521Estar-ZEK233806T2 PlusK233194TS Abutment SystemK232220SS Abutment SystemK232012N1

View all 31 devices →

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 GmbHK243190USTOMED 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.K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG

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.

↑