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1660
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126
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97
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433
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2868
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52
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515
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2428
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155
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LZA
Polymer Patient Examination Glove
407
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383
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358
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351
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302
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System, Imaging, Pulsed Doppler,...
296
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276
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
219
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Ortho Solutions UK , Ltd.
Medical Device Manufacturer
·
GB , Maldon
Ortho Solutions UK , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho Solutions UK , Ltd.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 07, 2025
Succession™ AFN System
K250622
·
HSB
Orthopedic
·
160d
Cleared
Feb 23, 2024
COGNiTiON™ Staple System
K240212
·
JDR
Orthopedic
·
29d
Cleared
Apr 13, 2021
Volition Plating System
K210658
·
HRS
Orthopedic
·
40d
Cleared
Nov 20, 2020
Ortho Solutions Plating System
K202764
·
HRS
Orthopedic
·
60d
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Orthopedic
4