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FDA 510(k) Application Details - K201850
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K201850
Device Name
Screw, Fixation, Bone
Applicant
Nvision Biomedical Technologies, Inc
4590 Lockhill Selma
San Antonio, TX 78249 US
Other 510(k) Applications for this Company
Contact
Diana Langham
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
07/06/2020
Decision Date
08/04/2020
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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