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FDA 510(k) Application Details - K230945
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K230945
Device Name
Screw, Fixation, Bone
Applicant
Forma Medical, Inc.
3401 Hartzdale Drive, Suite 103B, Unit #611
Camp Hill, PA 17011 US
Other 510(k) Applications for this Company
Contact
James A. Gault
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
04/04/2023
Decision Date
07/18/2023
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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