Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar |
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510(k) Number | K111122 | |||
Device Name | AESCULAP SIBD XP SPINAL SYSTEM | |||
Applicant |
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Applicant Contact | lisa m boyle | |||
Correspondent |
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Correspodent Contact | lisa m boyle | |||
Regulation Number | 888.3080 | |||
Classification Product Code |
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Date Received | 04/21/2011 | |||
Decision Date | 08/04/2011 | |||
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 |