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FDA 510(k) Application Details - K992920
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K992920
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact
JONAS WILF
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
08/30/1999
Decision Date
11/23/1999
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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