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FDA 510(k) Applications Submitted by John Urtz
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140414
02/18/2014
IMBIBE NEEDLE
ORTHOVITA, INC.
K140868
04/03/2014
STRYKER KWIC NEEDLE
ORTHOVITA, INC.
K162102
07/29/2016
MAGNETOM Avantofit, MAGNETOM Skyrafit
SIEMENS MEDICAL SOLUTIONS, INC.
K153343
11/19/2015
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
SIEMENS MEDICAL SOLUTIONS, INC.
K153360
11/20/2015
ADMIRE
SIEMENS MEDICAL SOLUTIONS, INC.
K214070
12/27/2021
OviTex PRS (Long Term Resorbable)
TELA Bio
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