FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCIN HIP SYSTEM
K Number: K073068
·
Decision Jan 10, 2008
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
7
Review Days
72
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Basic Information
- Device Name
- ACCIN HIP SYSTEM
- K Number
- K073068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accelerated Innovation, LLC
- Date Received
- October 30, 2007
- Decision Date
- January 10, 2008
- 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 Accelerated Innovation, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K081127 | ACCIN TOTAL KNEE SYSTEM | Oct 17, 2008 | Substantially Equivalent |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Jul 8, 2008 | Substantially Equivalent |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Jun 2, 2008 | Substantially Equivalent |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Feb 29, 2008 | Substantially Equivalent |
| K073531 | ACCIN PEDICLE SCREW SYSTEM | Feb 4, 2008 | Substantially Equivalent |
| K073530 | ACCIN ANTERIOR CERVICAL PLATE SYSTEM | Jan 31, 2008 | Substantially Equivalent |