510k
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331
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148
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97
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72
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242
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2038
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309
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1575
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131
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227
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208
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207
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205
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System, Image Processing,...
197
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
168
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Abutment, Implant, Dental,...
153
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Intervertebral Fusion Device...
137
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Thoracolumbosacral Pedicle Screw...
135
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Core Essence Orthopaedics, LLC
Medical Device Manufacturer
·
US , Yardley , PA
Core Essence Orthopaedics, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2007
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Core Essence Orthopaedics, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 15, 2007
REVERTO 55 AND 37 SHAPE MEMORY STAPLES
K071477
·
JDR
Orthopedic
·
78d
Cleared
Aug 10, 2007
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
K071520
·
MBI
Orthopedic
·
67d
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3
Orthopedic
2
General & Plastic Surgery
1