| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | C2 A-TAPER ACETABULAR SYSTEM |
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| Classification Name | prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | BIOMET, INC. |
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| PMA Number | P050009 |
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| Date Received | 03/14/2005 |
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| Decision Date | 12/16/2005 |
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| Product Code | |
| Docket Number | 06M-0015 |
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| Notice Date | 01/13/2006 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the c2a-taper acetabular system. The device is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S004 S005 S007 |
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