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FDA 510(k) Application Details - K210016
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K210016
Device Name
Plate, Fixation, Bone
Applicant
Integra Lifesciences Corporation
11101 Metric Blvd
Austin, TX 78758 US
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Contact
Blesson Abraham
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
01/04/2021
Decision Date
07/27/2021
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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