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FDA 510(k) Application Details - K081145
Device Classification Name
Orthosis, Spinal Pedicle Fixation
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510(K) Number
K081145
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
SOLCO BIOMEDICAL CO., LTD.
155 GIBBS ST., SUITE 512
ROCKVILLE, MD 20850 US
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Contact
SAEYOUNG AHN
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
04/22/2008
Decision Date
11/05/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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