FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCIA TOTAL HIP SYSTEM
K Number: K042344
·
Decision Mar 16, 2005
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
207
Review Days
198
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Basic Information
- Device Name
- EXCIA TOTAL HIP SYSTEM
- K Number
- K042344
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- August 30, 2004
- Decision Date
- March 16, 2005
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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