510k
Database
Specialties
Anesthesiology
540
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1672
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362
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1335
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245
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964
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2190
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2043
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126
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97
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8
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466
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965
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433
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274
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2900
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52
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515
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2433
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Spinevision, S.A.S.
Medical Device Manufacturer
·
FR , Antony
Spinevision, S.A.S. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinevision, S.A.S.
Orthopedic
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 16, 2022
Hexanium PLIF
K223251
·
MAX
Orthopedic
·
56d
Cleared
Nov 14, 2022
Hexanium ACIF
K221578
·
OVE
Orthopedic
·
166d
Cleared
Mar 10, 2021
Hexanium TLIF
K210359
·
MAX
Orthopedic
·
30d
Cleared
Oct 20, 2020
Hexanium® ACIF
K193000
·
OVE
Orthopedic
·
358d
Cleared
May 04, 2018
Hexanium® TLIF
K180437
·
MAX
Orthopedic
·
73d
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Orthopedic
5