FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENERATION 4 BONE CEMENT
K Number: K993836
·
Decision Dec 19, 2001
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
441
Review Days
768
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Basic Information
- Device Name
- GENERATION 4 BONE CEMENT
- K Number
- K993836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- November 12, 1999
- Decision Date
- December 19, 2001
- 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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