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FDA 510(k) Applications Submitted by Sarah Marie Fitzgerald
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121732
06/13/2012
CANOPY LAMINOPLASTY FIXATION SYSTEM
GLOBUS MEDICAL INC.
K120092
01/11/2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
GLOBUS MEDICAL INC.
K121107
04/12/2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
GLOBUS MEDICAL, INC.
K111479
05/27/2011
REVERE CROSSTOP
GLOBUS MEDICAL INC.
K113395
11/17/2011
REVERE 4.5 STABILIZATION SYSTEM
GLOBUS MEDICAL INC.
K123783
12/10/2012
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
GLOBUS MEDICAL, INC.
K124058
12/31/2012
CREO STABILIZATION SYSTEM
GLOBUS MEDICAL INC.
K130392
02/15/2013
KINEX BIOACTIVE
GLOBUS MEDICAL INC.
K130478
02/25/2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
GLOBUS MEDICAL, INC.
K130977
04/09/2013
SIGNIFY BIOACTIVE
GLOBUS MEDICAL INC.
K111449
05/25/2011
REVOLVE ADDITIONAL IMPLANTS
GLOBUS MEDICAL, INC.
K180079
01/10/2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
Hill-Rom Inc.
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