FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCOLADE II HIP STEM
K Number: K120578
·
Decision Mar 29, 2012
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
13
Review Days
31
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Basic Information
- Device Name
- ACCOLADE II HIP STEM
- K Number
- K120578
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics
- Date Received
- February 27, 2012
- Decision Date
- March 29, 2012
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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