K253674
- 510(k) number
- K253674
- Device name
- Blueprint Patient-Specific Instrumentation
- Applicant
- Stryker Corporation (Tornier, S.A.S.) FR
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-04-03
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253674.pdf
Official FDA record: K253674
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.