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FDA 510(k) Application Details - K072426
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K072426
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
ATLAS SPINE LLC
1555 JUPITER PARK DR., STE. 4
JUPITER, FL 33458 US
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Contact
JEANETTE G DAILEY
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
08/29/2007
Decision Date
10/19/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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