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FDA 510(k) Application Details - K181603
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
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510(K) Number
K181603
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
K2M Inc.
600 Hope Pkwy. SE
Leesburg, VA 20175 US
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Contact
Nancy Giezen
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Regulation Number
000.0000
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Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
06/19/2018
Decision Date
10/05/2018
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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