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FDA 510(k) Application Details - K220359
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K220359
Device Name
Screw, Fixation, Bone
Applicant
Microware Precision Co., Ltd.
No. 12, Keyuan 2nd Rd., Situn District
Taichung 40763 TW
Other 510(k) Applications for this Company
Contact
Harrison Du
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
02/08/2022
Decision Date
09/20/2022
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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