Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
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510(k) Number | K121563 | ||||
Device Name | CORIN TRIFIT TS HIP | ||||
Applicant |
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Applicant Contact | lucinda gerber | ||||
Correspondent |
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Correspodent Contact | lucinda gerber | ||||
Regulation Number | 888.3353 | ||||
Classification Product Code |
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Subsequent Product Codes |
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Date Received | 05/29/2012 | ||||
Decision Date | 10/05/2012 | ||||
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 |