510k
Database
Specialties
Anesthesiology
469
Cardiovascular
1409
Chemistry
334
Dental
1114
Ear, Nose, Throat
206
Gastroenterology & Urology
833
General & Plastic Surgery
1860
General Hospital
1352
Hematology
124
Immunology
87
Medical Genetics
7
Microbiology
423
Neurology
797
Obstetrics & Gynecology
353
Ophthalmic
231
Orthopedic
2459
Pathology
48
Physical Medicine
426
Radiology
2035
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
301
LLZ
System, Image Processing,...
299
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
LZA
Polymer Patient Examination Glove
244
HRS
Plate, Fixation, Bone
242
OLO
Orthopedic Stereotaxic Instrument
202
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Orthomatrix, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Orthomatrix, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1984
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthomatrix, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738
·
HWC
Orthopedic
·
142d
Cleared
Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
K001254
·
JDQ
Orthopedic
·
238d
Cleared
Mar 10, 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850
·
HSB
Orthopedic
·
199d
Cleared
Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856
·
HSB
Orthopedic
·
199d
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8
Orthopedic
4
Dental
3
Chemistry
1