510k
Database
Specialties
Anesthesiology
430
Cardiovascular
1306
Chemistry
327
Dental
1004
Ear, Nose, Throat
190
Gastroenterology & Urology
781
General & Plastic Surgery
1697
General Hospital
1101
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
412
Neurology
732
Obstetrics & Gynecology
321
Ophthalmic
199
Orthopedic
2365
Pathology
44
Physical Medicine
393
Radiology
1898
Toxicology
140
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
239
IYN
System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
161
Browse all 339 categories →
Search
Reports
About
Home
Spinal Edge, LLC
Medical Device Manufacturer
·
US , Westlake , OH
Spinal Edge, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinal Edge, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 02, 2010
ATLAS INTERVERTEBRAL BODY CAGE
K092774
·
MAX
Orthopedic
·
146d
Cleared
Jul 24, 2009
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
K091110
·
MNH
Orthopedic
·
98d
Cleared
Jun 08, 2006
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
K060916
·
MQP
Orthopedic
·
65d
Filters
Filter by Specialty
All
3
Orthopedic
3