510k
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Anesthesiology
484
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1476
Chemistry
340
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1160
Ear, Nose, Throat
216
Gastroenterology & Urology
852
General & Plastic Surgery
1930
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1468
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125
Immunology
90
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8
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432
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834
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368
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249
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2539
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49
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452
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2088
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147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
285
GEI
Electrosurgical, Cutting &...
267
QIH
Automated Radiological Image...
258
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
175
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Orthopaedic Biosystems
Medical Device Manufacturer
·
US , Carlsbad , CA
Orthopaedic Biosystems - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 1991
3
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthopaedic Biosystems
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 12, 1994
XANCHOR SUTURE ATTACHMENT DEVICE
K932041
·
JDR
Orthopedic
·
472d
Cleared
Mar 12, 1993
BIOACTION LOW PROFILE SCREW SYSTEM
K922788
·
HWC
Orthopedic
·
276d
Cleared
Jun 28, 1991
ANATOMIC TOE SYSTEM
K911552
·
LZJ
Orthopedic
·
81d
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3
Orthopedic
3