FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K Number: K112030
·
Decision Jun 19, 2012
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
32
Applicant Total
2
Review Days
340
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Basic Information
- Device Name
- SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
- K Number
- K112030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3170
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes USA, LLC
- Date Received
- July 15, 2011
- Decision Date
- June 19, 2012
- 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 |
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Other Clearances by Synthes USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Nov 10, 2016 | Substantially Equivalent |