FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K Number: K083439
·
Decision Feb 5, 2009
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
34
Applicant Total
402
Review Days
77
Basic Information
- Device Name
- SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
- K Number
- K083439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYNTHES (USA)
- Date Received
- November 20, 2008
- Decision Date
- February 5, 2009
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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