510k
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97
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433
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2875
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52
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515
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2430
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155
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Polymer Patient Examination Glove
408
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383
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358
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351
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302
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296
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276
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269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
219
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Spectrum Spine, Inc.
Medical Device Manufacturer
·
US , Jasper , GA
Spectrum Spine, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spectrum Spine, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 24, 2025
Expandable Titanium PLIF/TLIF System
K253377
·
MAX
Orthopedic
·
24d
Cleared
Apr 04, 2025
Spectrum Spine Lumbar Cage System
K243074
·
MAX
Orthopedic
·
189d
Cleared
May 30, 2024
Spectrum Spine Cervical Cage System
K240838
·
ODP
Orthopedic
·
64d
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3
Orthopedic
3