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FDA 510(k) Application Details - K211292
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K211292
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Pega Medical Inc.
1111 Autoroute Chomedey
Laval H7W 5J8 CA
Other 510(k) Applications for this Company
Contact
Enrique Garcia
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/28/2021
Decision Date
05/26/2021
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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