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1985
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2599
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GEX
Powered Laser Surgical Instrument
324
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321
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Polymer Patient Examination Glove
297
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276
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Automated Radiological Image...
263
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System, Imaging, Pulsed Doppler,...
260
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Plate, Fixation, Bone
251
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Orthopedic Stereotaxic Instrument
215
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Abutment, Implant, Dental,...
201
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Intervertebral Fusion Device...
184
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Osteotomy Guide Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Osteotomy Guide Co. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1984
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteotomy Guide Co.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 12, 1986
SHORTENING OSTEOTOMY GUIDE
K861576
·
HTH
Orthopedic
·
14d
Cleared
Feb 19, 1986
REESE ARTHRODESIS SCREW
K860323
·
HWC
Orthopedic
·
21d
Cleared
May 23, 1984
REESE OSTEOTOMY GUIDE SYS
K841470
·
HTH
Orthopedic
·
44d
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Orthopedic
3