Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented |
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---|---|---|---|---|
510(k) Number | K030153 | |||
Device Name | ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 | |||
Original Applicant |
|
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Original Contact | karen cain | |||
Regulation Number | 888.3350 | |||
Classification Product Code |
|
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Date Received | 01/16/2003 | |||
Decision Date | 04/01/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Orthopedic |
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510k Review Panel |
Orthopedic |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |