FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESCALADE ACETABULAR CUP SYSTEM
K Number: K103384
·
Decision Mar 16, 2011
Classifications
1
FEI Numbers
271
Registration Numbers
271
Same Product Code
551
Applicant Total
5
Review Days
118
Basic Information
- Device Name
- ESCALADE ACETABULAR CUP SYSTEM
- K Number
- K103384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORTHO DEVELOPMENT
- Date Received
- November 18, 2010
- Decision Date
- March 16, 2011
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K111965 | VUSION(R) OS | Oct 25, 2011 | Substantially Equivalent |
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