FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCEND SHOULDER SYSTEM
K Number: K113413
·
Decision Mar 9, 2012
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
186
Applicant Total
34
Review Days
112
Basic Information
- Device Name
- ASCEND SHOULDER SYSTEM
- K Number
- K113413
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TORNIER, INC.
- Date Received
- November 18, 2011
- Decision Date
- March 9, 2012
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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