FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL AND HEMI SHOULDER SYSTEM
K Number: K060988
·
Decision Dec 6, 2006
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
4
Review Days
240
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Basic Information
- Device Name
- TOTAL AND HEMI SHOULDER SYSTEM
- K Number
- K060988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dvo Extremity Solutions, LLC
- Date Received
- April 10, 2006
- Decision Date
- December 6, 2006
- 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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