510k
Database
Specialties
Anesthesiology
387
Cardiovascular
1202
Chemistry
296
Dental
896
Ear, Nose, Throat
168
Gastroenterology & Urology
710
General & Plastic Surgery
1530
General Hospital
913
Hematology
110
Immunology
78
Medical Genetics
2
Microbiology
393
Neurology
664
Obstetrics & Gynecology
285
Ophthalmic
177
Orthopedic
2194
Pathology
42
Physical Medicine
360
Radiology
1755
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
227
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
214
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Orthovita, Inc.
Medical Device Manufacturer
·
US , Malver , PA
Orthovita, Inc. - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 2001
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthovita, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 18, 2015
Imbibe Needle
K153306
·
KNW
Gastroenterology & Urology
·
32d
Cleared
Jun 03, 2005
IMBIBE BONE MARROW ASPIRATION NEEDLE
K050795
·
KNW
Gastroenterology & Urology
·
66d
Filters
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23
Orthopedic
15
General Hospital
4
Gastroenterology & Urology
2
Dental
1
Neurology
1