510k
Database
Specialties
Anesthesiology
455
Cardiovascular
1381
Chemistry
334
Dental
1079
Ear, Nose, Throat
198
Gastroenterology & Urology
821
General & Plastic Surgery
1816
General Hospital
1255
Hematology
123
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85
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7
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420
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773
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341
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217
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2434
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46
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416
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1999
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143
Categories
GEX
Powered Laser Surgical Instrument
296
LLZ
System, Image Processing,...
288
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
214
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Theken Surgical
Medical Device Manufacturer
·
US , Akron , OH
Theken Surgical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Theken Surgical
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 16, 2004
CORAL SPINAL SYSTEM
K041592
·
KWP
Orthopedic
·
94d
Cleared
Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382
·
HWC
Orthopedic
·
73d
Cleared
Feb 04, 2000
DOGBONE ACFS
K994383
·
KWQ
Orthopedic
·
38d
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3
Orthopedic
3