FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoreHip® System
K Number: K172235
·
Decision Mar 28, 2018
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
3
Review Days
246
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Basic Information
- Device Name
- CoreHip® System
- K Number
- K172235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap Implants Systems, LLC
- Date Received
- July 25, 2017
- Decision Date
- March 28, 2018
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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