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3153
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530
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2813
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1219
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2299
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1992
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991
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546
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8334
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340
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777
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698
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632
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620
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528
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522
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Polymer Patient Examination Glove
490
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System, Nuclear Magnetic...
485
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Intervertebral Fusion Device...
451
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Thoracolumbosacral Pedicle Screw...
443
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510k Database
Manufacturers
US
Orthomet, Inc.
Medical Device Manufacturer
·
US , Plymouth , MN
Orthomet, Inc. - FDA 510(k) Cleared Devices
60 submissions
·
41 cleared
·
Since 1986
60
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthomet, Inc.
Microbiology
✕
1
devices
1-1 of 1
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Cleared
Jun 18, 1990
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259
·
JWX
Microbiology
·
28d
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60
Orthopedic
58
Ophthalmic
1
Microbiology
1