FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K Number: K201072
·
Decision Dec 2, 2020
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
1
Review Days
224
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Basic Information
- Device Name
- Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
- K Number
- K201072
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ensemble Orthopedics, LLC
- Date Received
- April 22, 2020
- Decision Date
- December 2, 2020
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
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