K241878
- 510(k) number
- K241878
- Device name
- Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
- Applicant
- Stryker Corporation (Tornier, Inc.) MN · US
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2024-12-06
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K241878.pdf
Official FDA record: K241878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.