K232425
- 510(k) number
- K232425
- Device name
- Signature ONE System
- Applicant
- Orthosoft Inc. (D/B/A) Zimmer Cas) CA
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2023-12-12
- Date received
- 2023-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K232425.pdf
Official FDA record: K232425
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.