K232265
- 510(k) number
- K232265
- Device name
- BLUEPRINT Patient Specific Instrumentation
- Applicant
- Tornier S.A.S. FR
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2024-02-21
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232265.pdf
Official FDA record: K232265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.