FDA 510(k)

Bone Screw

K-Number: K251569 · 2025-08-13

Decision Date2025-08-13

Product CodeDZL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Bone Screw is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under approval 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. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K251569.

When was Bone Screw approved by the FDA?

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

What company makes Bone Screw?

Bone Screw is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for Bone Screw?

The FDA product code for Bone Screw is DZL.

Other Devices by Osstem Implant Co., Ltd.

K161197Orthodontic Screw K153015Transfer & Angled Abutment K160519Link Abutment for CEREC K161604OSSTEM Implant System K170736HySil Impression Materials K161689OSSTEM Implant System - Abutment

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Related Devices (Code: DZL)

K151540MC BIO Supertack Tack 3mm, 4mm and 5mmEli-Ka Technologies K171831Intra-Lock Bone Fixation SystemIntra-Lock International, Inc. K161857Salvin Tenting Screw SystemSalvin Dental Specialties K160991Neo GBR SystemNeobiotech Co., Ltd. K182881Bone Screw, Bone TackOsstem Implant Co., Ltd. K181854OssBuilder SystemOsstem Implant Co., Ltd.

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.