FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K Number: K041352
·
Decision Jul 30, 2004
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
85
Applicant Total
441
Review Days
71
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Basic Information
- Device Name
- COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
- K Number
- K041352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3510
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- May 20, 2004
- Decision Date
- July 30, 2004
- Product Code
- KRO
- 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 |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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