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FDA 510(k) Application Details - K053070
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K053070
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
ALTIVA CORP.
9800-I SOUTHERN PINE BLVD.
CHARLOTTE, NC 28273 US
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Contact
JOHN KAPTIAN
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
11/01/2005
Decision Date
02/13/2006
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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