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FDA 510(k) Application Details - K212297
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K212297
Device Name
Plate, Fixation, Bone
Applicant
Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 US
Other 510(k) Applications for this Company
Contact
Brian Smekal
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
07/22/2021
Decision Date
08/20/2021
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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