| Device Classification Name |
orthosis, spinal pedicle fixation, for degenerative disc disease |
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|---|---|---|---|---|---|
| 510(k) Number | K121619 | ||||
| Device Name | NUVASIVE POLYAXIAL SPINAL SCREWS | ||||
| Applicant |
|
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| Applicant Contact | elias ketchum | ||||
| Correspondent |
|
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| Correspodent Contact | elias ketchum | ||||
| Regulation Number | 888.3070 | ||||
| Classification Product Code |
|
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| Subsequent Product Codes |
|
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| Date Received | 06/01/2012 | ||||
| Decision Date | 08/24/2012 | ||||
| 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 | Special | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |