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FDA 510(k) Application Details - K070573
Device Classification Name
Orthosis, Spinal Pedicle Fixation
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510(K) Number
K070573
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact
SUSAN LEWANDOWSKI
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
02/28/2007
Decision Date
06/08/2007
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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