FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FIDJI SMALL CEMENT RESTRICTOR
K Number: K030767
·
Decision Dec 22, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
3
Review Days
286
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Basic Information
- Device Name
- FIDJI SMALL CEMENT RESTRICTOR
- K Number
- K030767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Spine Next SA
- Date Received
- March 11, 2003
- Decision Date
- December 22, 2003
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
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