510k
Database
Specialties
Anesthesiology
407
Cardiovascular
1228
Chemistry
305
Dental
926
Ear, Nose, Throat
177
Gastroenterology & Urology
725
General & Plastic Surgery
1576
General Hospital
961
Hematology
112
Immunology
79
Medical Genetics
4
Microbiology
400
Neurology
688
Obstetrics & Gynecology
294
Ophthalmic
183
Orthopedic
2221
Pathology
43
Physical Medicine
369
Radiology
1803
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
259
LLZ
System, Image Processing,...
251
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
223
GEI
Electrosurgical, Cutting &...
220
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
183
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
146
Browse all 339 categories →
Search
Reports
About
Home
New Era Orthopedics, LLC
Medical Device Manufacturer
·
US , Hummelstown , PA
New Era Orthopedics, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2014
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - New Era Orthopedics, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 08, 2015
Polyscrew Pedicle Screw System
K150647
·
MNI
Orthopedic
·
27d
Cleared
Dec 05, 2014
Neo Total Knee System
K142388
·
JWH
Orthopedic
·
100d
Filters
Filter by Specialty
All
2
Orthopedic
2