FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVASIVE MESH
K Number: K020853
·
Decision Jun 13, 2002
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
11
Applicant Total
91
Review Days
90
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Basic Information
- Device Name
- NUVASIVE MESH
- K Number
- K020853
- 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
- Nuvasive, Inc.
- Date Received
- March 15, 2002
- Decision Date
- June 13, 2002
- Product Code
- EZX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| EZX | Mesh, Surgical, Metal | FDA class 2 | General, Plastic Surgery |
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