FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMENTRALIZER DISTAL STEM CENTRALIZER
K Number: K951930
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
303
Review Days
97
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Basic Information
- Device Name
- CEMENTRALIZER DISTAL STEM CENTRALIZER
- K Number
- K951930
- 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
- Depuy, Inc.
- Date Received
- April 5, 1995
- Decision Date
- July 11, 1995
- Product Code
- LZN
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
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