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2900
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276
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270
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Orthopedic Stereotaxic Instrument
227
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Intervertebral Fusion Device...
219
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Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Medical Device Manufacturer
·
CN , Changzhou
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. - FDA 5...
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 15, 2023
Internal Locking Plate and Screw Fixation System
K232394
·
HRS
Orthopedic
·
128d
Cleared
Jun 30, 2023
SGM Femoral Nail System
K230456
·
HSB
Orthopedic
·
129d
Cleared
Mar 03, 2023
PEEK Spinal Infusion Cage
K223776
·
MAX
Orthopedic
·
77d
Cleared
Oct 28, 2022
Spinal Inner Fixation System
K222031
·
NKB
Orthopedic
·
109d
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Orthopedic
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