510k
Database
Specialties
Anesthesiology
440
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1343
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331
Dental
1036
Ear, Nose, Throat
192
Gastroenterology & Urology
796
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1757
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1168
Hematology
118
Immunology
84
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7
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414
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751
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331
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205
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2401
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44
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402
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1942
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141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
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Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
234
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
190
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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N-Spine, Inc.
Medical Device Manufacturer
·
US , Stillwater , MN
N-Spine, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
1 cleared
·
Since 2006
3
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - N-Spine, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 19, 2007
NGARDE SYSTEM
K072685
·
NQP
Orthopedic
·
28d
Cleared
Dec 13, 2006
NFIX II PEDICLE SCREW SYSTEM
K061774
·
NQP
Orthopedic
·
173d
Cleared
Jul 12, 2006
NFIX FUSION SYSTEM
K053623
·
MNH
Orthopedic
·
196d
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3
Orthopedic
3