Device Classification Name |
fastener, fixation, nondegradable, soft tissue |
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510(k) Number | K122123 | |||
Device Name | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED | |||
Applicant |
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Applicant Contact | julie vafides | |||
Correspondent |
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Correspodent Contact | julie vafides | |||
Regulation Number | 888.3040 | |||
Classification Product Code |
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Date Received | 07/18/2012 | |||
Decision Date | 10/02/2012 | |||
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 |