510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1493
Chemistry
343
Dental
1177
Ear, Nose, Throat
216
Gastroenterology & Urology
859
General & Plastic Surgery
1942
General Hospital
1493
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
848
Obstetrics & Gynecology
370
Ophthalmic
250
Orthopedic
2565
Pathology
49
Physical Medicine
455
Radiology
2124
Toxicology
148
Categories
GEX
Powered Laser Surgical Instrument
317
LLZ
System, Image Processing,...
314
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
256
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
199
MAX
Intervertebral Fusion Device...
178
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Westcon Orthopedics, Inc.
Medical Device Manufacturer
·
US , Three Bridges , NJ
Westcon Orthopedics, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Westcon Orthopedics, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 09, 1992
K-CAP-E, STERILE
K914812
·
LYT
Orthopedic
·
76d
Cleared
Jul 18, 1991
K-CAP-I, STERILE
K912762
·
LYT
Orthopedic
·
24d
Cleared
Sep 14, 1990
K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
K902053
·
LYT
Orthopedic
·
130d
Cleared
Apr 23, 1990
K-CAPE ORTHOPEDIC WIRES AND PINS
K901525
·
KTT
Orthopedic
·
21d
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4
Orthopedic
4