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FDA 510(k) Application Details - K150294
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K150294
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
Osteomed Implantes, LTDA
Washington Luiz Road, km 172, Condominio Conpark - Rua 6
Rio Claro 13501-600 BR
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Contact
J. D. Webb
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
02/06/2015
Decision Date
06/05/2015
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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