Orthovita, Inc. is one of 15035 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthovita, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Vitoss Bioactive (BA) Injectable, HydroSet XT, Vitoss BiModal Bone Graft Substitute Foam Strip
23
Total
23
Cleared
0
Denied
Orthovita, Inc. has 23 FDA 510(k) cleared medical devices. Based in Malver, US.
Historical record: 23 cleared submissions from 2001 to 2017. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Orthovita, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Stryker Corporation as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Orthovita, Inc.
23 devices
Cleared
May 02, 2017
Vitoss Bioactive (BA) Injectable
Orthopedic
131d
Cleared
Oct 06, 2016
HydroSet XT
Orthopedic
134d
Cleared
Feb 12, 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
Orthopedic
57d
Cleared
Dec 18, 2015
Imbibe Needle
Gastroenterology & Urology
32d
Cleared
Jun 05, 2014
STRYKER KWIC NEEDLE
Neurology
63d
Cleared
Apr 01, 2014
IMBIBE NEEDLE
Orthopedic
42d
Cleared
Feb 07, 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
Orthopedic
102d
Cleared
Jan 25, 2011
ORTHOVITA PEEK SPACER
Orthopedic
274d
Cleared
Oct 27, 2010
FM-02 BONE GRAFT SUBSTITUTE
Orthopedic
54d
Cleared
Sep 27, 2010
VITOMATRIX
Dental
481d
Cleared
CT
Jun 05, 2009
CORTOSS BONE AUGMENTATION MATERIAL
Orthopedic
507d
Cleared
Nov 06, 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM &...
Orthopedic
27d