K260104
- 510(k) number
- K260104
- Device name
- Signature ONE System
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS CA
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2026-02-04
- Date received
- 2026-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260104.pdf
Official FDA record: K260104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.