Device Classification Name |
orthosis, spinal pedicle fixation |
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---|---|---|---|---|
510(k) Number | K122163 | |||
Device Name | CERTEX SPINAL IMPLANT SYSTEM | |||
Applicant |
|
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Applicant Contact | david kirschman | |||
Correspondent |
|
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Correspodent Contact | david kirschman | |||
Regulation Number | 888.3070 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 07/20/2012 | |||
Decision Date | 10/31/2012 | |||
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 |