FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Signature ONE System
K Number: K260104
·
Decision Feb 4, 2026
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
5
Review Days
22
Basic Information
- Device Name
- Signature ONE System
- K Number
- K260104
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS
- Date Received
- January 13, 2026
- Decision Date
- February 4, 2026
- Product Code
- QHE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QHE | Shoulder Arthroplasty Implantation System | FDA class 2 | Orthopedic |
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