FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K Number: K033382
·
Decision Feb 5, 2004
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
207
Review Days
105
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Basic Information
- Device Name
- SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
- K Number
- K033382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- October 23, 2003
- Decision Date
- February 5, 2004
- Product Code
- LOD
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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