K252443
- 510(k) number
- K252443
- Device name
- SpaceFix Shoulder Spacer
- Applicant
- G21, S.R.L. IT
- Product code
- MBB — Bone Cement, Antibiotic
- Decision date
- 2025-09-15
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252443.pdf
Official FDA record: K252443
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.