Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer |
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510(k) Number | K992287 | |||
Device Name | FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM | |||
Applicant |
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Applicant Contact | karen ariemma | |||
Correspondent |
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Correspodent Contact | karen ariemma | |||
Regulation Number | 888.3520 | |||
Classification Product Code |
|
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Date Received | 07/07/1999 | |||
Decision Date | 11/16/1999 | |||
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 |