FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Signature ONE System
K Number: K212560
·
Decision Oct 12, 2021
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
14
Review Days
60
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Basic Information
- Device Name
- Signature ONE System
- K Number
- K212560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
- Date Received
- August 13, 2021
- Decision Date
- October 12, 2021
- 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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Other Clearances by Orthosoft Inc (D/B/A Zimmer Cas)
| K Number | Device Name | ||
|---|---|---|---|
| K233199 | ROSA® Shoulder System | Feb 21, 2024 | Substantially Equivalent |
| K230567 | OptiVu ROSA® MxR | Jun 13, 2023 | Substantially Equivalent |
| K231162 | ROSA Hip System | May 23, 2023 | Substantially Equivalent |
| K230180 | Rosa Knee System | Feb 22, 2023 | Substantially Equivalent |
| K220733 | OptiVu ROSA MxR | Jul 29, 2022 | Substantially Equivalent |
| K213708 | ROSA® Knee System | Apr 22, 2022 | Substantially Equivalent |
| K200615 | Signature ONE System | Jun 5, 2020 | Substantially Equivalent |
| K192080 | iASSIST Knee System | Nov 5, 2019 | Substantially Equivalent |
| K192074 | Signature ONE System | Aug 30, 2019 | Substantially Equivalent |
| K183544 | Efficient Care 3D Planning | Aug 23, 2019 | Substantially Equivalent |