| 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 | S008 |
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| Date Received | 09/19/2006 |
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| Decision Date | 10/18/2006 |
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| Product Code | |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Special Supplement |
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| Supplement Reason | labeling change - instructions |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for changes to the warnings and precautions section of the package insert labeling to include additional statements that advise the surgeon to avoid the taper region and shell face of the metal acetabular shell component when impacting the shell to adjust the position of the component. |
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