K253858
- 510(k) number
- K253858
- Device name
- GFS - Sterile Screws and Top Hat
- Applicant
- T.A.G. Medical Products Corporation, Ltd. IL
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2026-08-05
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253858.pdf
Official FDA record: K253858
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.