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FDA 510(k) Application Details - K150507
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K150507
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
LANTERNA MEDICAL TECHNOLOGIES
294 RORSCHACHERSTRASSE
ST.GALLEN 9016 CH
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Contact
Horace Hale
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
02/26/2015
Decision Date
04/03/2015
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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