FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
K Number: K070061
·
Decision Jan 31, 2007
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
12
Review Days
26
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Basic Information
- Device Name
- 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
- K Number
- K070061
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hayes Medical, Inc.
- Date Received
- January 5, 2007
- Decision Date
- January 31, 2007
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Hayes Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062383 | UNISYN HA PLASMA MODULAR HIP | Dec 21, 2006 | Substantially Equivalent |
| K060635 | CONSENSUS ACETABULAR SHELL SYSTEM | Apr 28, 2006 | Substantially Equivalent |
| K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Apr 1, 2003 | Substantially Equivalent |
| K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE | Jul 24, 2002 | Substantially Equivalent |
| K020153 | CONSENSUS ACETABLAR SHELL, TI COATED | Apr 15, 2002 | Substantially Equivalent |
| K003649 | TRITON HIP SYSTEM | Feb 23, 2001 | Substantially Equivalent |
| K001456 | CONSENSUS KNEE SYSTEM | Aug 7, 2000 | Substantially Equivalent |
| K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI | Nov 25, 1998 | Substantially Equivalent |
| K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT | Jan 27, 1997 | Substantially Equivalent |