FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALIGN Radial Head System
K Number: K231188
·
Decision Sep 28, 2023
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
32
Applicant Total
20
Review Days
155
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Basic Information
- Device Name
- ALIGN Radial Head System
- K Number
- K231188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3170
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Dynamics, Inc.
- Date Received
- April 26, 2023
- Decision Date
- September 28, 2023
- Product Code
- KWI
- 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 |
|---|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Align Radial Head System
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