FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K Number: K022615
·
Decision Oct 29, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
- K Number
- K022615
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Centerpulse Spine-Tech, Inc.
- Date Received
- August 7, 2002
- Decision Date
- October 29, 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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