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FDA 510(k) Application Details - K191212
Device Classification Name
More FDA Info for this Device
510(K) Number
K191212
Device Name
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System,
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle 2400 CH
Other 510(k) Applications for this Company
Contact
Sergio M. Cordeiro
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2019
Decision Date
09/24/2019
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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