FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DVO EXTENDED ARTICULATION HUMERAL HEADS
K Number: K073331
·
Decision Feb 19, 2008
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
70
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- DVO EXTENDED ARTICULATION HUMERAL HEADS
- K Number
- K073331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3690
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dvo Extremity Solutions, LLC
- Date Received
- November 27, 2007
- Decision Date
- February 19, 2008
- Product Code
- HSD
- 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 |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | FDA class 2 | Orthopedic |
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