FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K Number: K040611
·
Decision Jun 4, 2004
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
32
Applicant Total
441
Review Days
88
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Basic Information
- Device Name
- MODULAR RADIAL HEAD REPLACEMENT DEVICE
- K Number
- K040611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3170
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- March 8, 2004
- Decision Date
- June 4, 2004
- Product Code
- KWI
- 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 |
|---|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | FDA class 2 | Orthopedic |
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