FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
K Number: K052086
·
Decision Aug 31, 2005
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
- K Number
- K052086
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical, Inc.
- Date Received
- August 2, 2005
- Decision Date
- August 31, 2005
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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