| Device Classification Name |
plate, fixation, bone |
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|---|---|---|---|---|---|
| 510(k) Number | K131480 | ||||
| Device Name | EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM | ||||
| Applicant |
|
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| Applicant Contact | victoria trafka | ||||
| Correspondent |
|
||||
| Correspodent Contact | victoria trafka | ||||
| Regulation Number | 888.3030 | ||||
| Classification Product Code |
|
||||
| Subsequent Product Code |
|
||||
| Date Received | 05/22/2013 | ||||
| Decision Date | 07/03/2013 | ||||
| Decision |
substantially equivalent (SESE) |
||||
| Regulation Medical Specialty |
Orthopedic |
||||
| 510k Review Panel |
Orthopedic |
||||
| summary |
summary |
||||
| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |