FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCIA
K Number: K061699
·
Decision Aug 18, 2006
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
207
Review Days
63
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Basic Information
- Device Name
- EXCIA
- K Number
- K061699
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- June 16, 2006
- Decision Date
- August 18, 2006
- 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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