510k
Database
Specialties
Anesthesiology
383
Cardiovascular
1193
Chemistry
289
Dental
884
Ear, Nose, Throat
164
Gastroenterology & Urology
699
General & Plastic Surgery
1510
General Hospital
888
Hematology
108
Immunology
78
Medical Genetics
1
Microbiology
389
Neurology
653
Obstetrics & Gynecology
278
Ophthalmic
173
Orthopedic
2183
Pathology
41
Physical Medicine
354
Radiology
1738
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
252
QIH
Automated Radiological Image...
229
LLZ
System, Image Processing,...
224
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
210
OLO
Orthopedic Stereotaxic Instrument
181
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
Browse all 339 categories →
Search
Reports
About
Home
Custom Orthopaedic Solutions, Inc.
Medical Device Manufacturer
·
US , Cleveland , OH
Custom Orthopaedic Solutions, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2014
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Custom Orthopaedic Solutions, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 15, 2016
ArthrexVIP Web Portal
K153612
·
LLZ
Radiology
·
89d
Cleared
Oct 02, 2015
OrthoVis Web Portal
K151501
·
LLZ
Radiology
·
120d
Cleared
Jul 31, 2015
Arthrex OrthoVis Preoperative Plan
K151568
·
LLZ
Radiology
·
51d
Filters
Filter by Specialty
All
6
Orthopedic
3
Radiology
3