FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2GC HIP/KNEE MODULAR SPACER
K Number: K112470
·
Decision Apr 5, 2012
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
1
Review Days
223
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Basic Information
- Device Name
- 2GC HIP/KNEE MODULAR SPACER
- K Number
- K112470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mandell Horwitz Consultants, LLC
- Date Received
- August 26, 2011
- Decision Date
- April 5, 2012
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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