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FDA 510(k) Application Details - K082698
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K082698
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG, VA 20175 US
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Contact
RICHARD WOODS
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
09/15/2008
Decision Date
04/21/2009
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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