FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMENT RESTRICTOR, SMALL AND LARGE
K Number: K021765
·
Decision Aug 16, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
186
Review Days
79
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Basic Information
- Device Name
- CEMENT RESTRICTOR, SMALL AND LARGE
- K Number
- K021765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- May 29, 2002
- Decision Date
- August 16, 2002
- 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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