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FDA 510(k) Application Details - K052971
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K052971
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE, NJ 07401 US
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Contact
SIMONA VOIC
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
10/24/2005
Decision Date
11/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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