| Device Classification Name |
orthosis, spinal pedicle fixation |
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|---|---|---|---|---|
| 510(k) Number | K131522 | |||
| Device Name | CORE PEDICLE SCREW SYSTEM | |||
| Applicant |
|
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| Applicant Contact | lisa peterson | |||
| Correspondent |
|
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| Correspodent Contact | lisa peterson | |||
| Regulation Number | 888.3070 | |||
| Classification Product Code |
|
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| Subsequent Product Codes |
|
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| Date Received | 05/28/2013 | |||
| Decision Date | 08/09/2013 | |||
| 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 |