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FDA 510(k) Application Details - K070276
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K070276
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
MEDICREA TECHNOLOGIES
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
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Contact
J. D WEBB
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
01/29/2007
Decision Date
09/21/2007
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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