Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented |
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510(k) Number | K033580 | |||
Device Name | NEXFLEX TOTAL HIP SYSTEM | |||
Applicant |
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Applicant Contact | ellen a yarnall | |||
Correspondent |
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Correspodent Contact | ellen a yarnall | |||
Regulation Number | 888.3358 | |||
Classification Product Code |
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Subsequent Product Codes |
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Date Received | 11/13/2003 | |||
Decision Date | 08/05/2004 | |||
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 | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |