FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smart SPACE Shoulder System
K Number: K202151
·
Decision Feb 3, 2021
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
3
Review Days
184
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Basic Information
- Device Name
- Smart SPACE Shoulder System
- K Number
- K202151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techmah Medical, LLC
- Date Received
- August 3, 2020
- Decision Date
- February 3, 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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