| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | DURALOC OPTION CERAMIC HIP SYSTEM |
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| Classification Name | prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Generic Name | total hip system,ceramic articulation |
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| Applicant | DEPUY ORTHOPAEDICS, INC. |
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| PMA Number | P040023 |
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| Supplement Number | S001 |
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| Date Received | 09/02/2005 |
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| Decision Date | 02/01/2006 |
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| Product Code | |
| Advisory Committee |
Orthopedic |
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| Supplement Type | 135 review track for 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for manufacturing process changes by ceramtec, inc. For the biolox forte ceramic femoral heads and inserts. |
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