FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICONACY(TM) I-Hip (TM)
K Number: K151307
·
Decision Feb 26, 2016
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
6
Review Days
284
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Basic Information
- Device Name
- ICONACY(TM) I-Hip (TM)
- K Number
- K151307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iconacy Orthopedic Implants, LLC
- Date Received
- May 18, 2015
- Decision Date
- February 26, 2016
- 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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Other Clearances by Iconacy Orthopedic Implants, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K160266 | ICONACY(TM) I-Hip(TM) | Apr 8, 2016 | Substantially Equivalent |
| K132572 | I-HIP TOTAL HIP SYSTEM | Mar 28, 2014 | Substantially Equivalent |
| K133228 | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM | Jan 17, 2014 | Substantially Equivalent |
| K131279 | ICONACY I-HIP SYSTEM | Aug 9, 2013 | Substantially Equivalent |
| K121034 | IOI TOTAL HIP | Sep 4, 2012 | Substantially Equivalent |