FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biocore9 Femoral Head Resurfacing Component
K Number: K201219
·
Decision Jan 19, 2021
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
22
Applicant Total
3
Review Days
258
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Basic Information
- Device Name
- Biocore9 Femoral Head Resurfacing Component
- K Number
- K201219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocore9, LLC
- Date Received
- May 6, 2020
- Decision Date
- January 19, 2021
- Product Code
- KXA
- 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 |
|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | FDA class 2 | Orthopedic |
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