K251569
- 510(k) number
- K251569
- Device name
- Bone Screw
- Applicant
- Osstem Implant Co., Ltd. KR
- Product code
- DZL — Screw, Fixation, Intraosseous
- Decision date
- 2025-08-13
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251569.pdf
Official FDA record: K251569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.