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FDA 510(k) Application Details - K070688
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K070688
Device Name
Staple, Fixation, Bone
Applicant
NEXA ORTHOPEDICS, INC.
11035 ROSELLE STREET
SAN DIEGO, CA 92121 US
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Contact
LOUISE M FOCHT
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Regulation Number
888.3030
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Classification Product Code
JDR
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More FDA Info for this Product Code
Date Received
03/12/2007
Decision Date
05/18/2007
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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