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FDA 510(k) Application Details - K223392
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K223392
Device Name
Screw, Fixation, Bone
Applicant
Voom Medical Devices, Inc.
800A 5th Avenue, Suite #403
New York City, NY 10065 US
Other 510(k) Applications for this Company
Contact
Neal M Blitz
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2022
Decision Date
02/28/2023
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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