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FDA 510(k) Application Details - K100845
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K100845
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
ZIMMER SPINE, INC
5301 RIATA PARK COURT
BUILDING F
AUSTIN, TX 78727 US
Other 510(k) Applications for this Company
Contact
DAVID PADGETT, RAC (US)
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
03/25/2010
Decision Date
09/21/2010
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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