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FDA 510(k) Application Details - K021335
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K021335
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
LISA GILMAN
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
04/26/2002
Decision Date
07/11/2002
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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