FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IOI TOTAL HIP
K Number: K121034
·
Decision Sep 4, 2012
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
6
Review Days
152
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Basic Information
- Device Name
- IOI TOTAL HIP
- K Number
- K121034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iconacy Orthopedic Implants, LLC
- Date Received
- April 5, 2012
- Decision Date
- September 4, 2012
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 |
| K151307 | ICONACY(TM) I-Hip (TM) | Feb 26, 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 |