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FDA 510(k) Application Details - K213005
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K213005
Device Name
Plate, Fixation, Bone
Applicant
GLW Medical Inc
300 Sylvan Ave
Englewood Cliff, NJ 07632 US
Other 510(k) Applications for this Company
Contact
Arundhati Radhakrishnan
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2021
Decision Date
03/11/2022
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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