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FDA 510(k) Application Details - K020885
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K020885
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
PEGA MEDICAL INC.
9260 VIAU BLVD.
ST-LEONARD (MONTREAL)
QUEBEC H1R 2V8 CA
Other 510(k) Applications for this Company
Contact
ARIEL R DUJOVNE
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
03/18/2002
Decision Date
02/06/2003
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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