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535
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523
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517
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489
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431
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Intervertebral Fusion Device...
406
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Screw, Fixation, Bone
401
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Manufacturers
US
Rosys, Inc.
Medical Device Manufacturer
·
US , Wilmington , DE
Rosys, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1994
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rosys, Inc.
Chemistry
✕
2
devices
1-2 of 2
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Cleared
Jan 09, 1995
PLATO 3300/1300
K943454
·
JJQ
Chemistry
·
175d
Cleared
Feb 25, 1994
PLATO 3000
K933088
·
JQW
Chemistry
·
247d
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Chemistry
2