510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1501
Chemistry
343
Dental
1186
Ear, Nose, Throat
216
Gastroenterology & Urology
862
General & Plastic Surgery
1958
General Hospital
1516
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
436
Neurology
857
Obstetrics & Gynecology
377
Ophthalmic
252
Orthopedic
2580
Pathology
49
Physical Medicine
459
Radiology
2145
Toxicology
152
Categories
LLZ
System, Image Processing,...
319
GEX
Powered Laser Surgical Instrument
319
LZA
Polymer Patient Examination Glove
294
GEI
Electrosurgical, Cutting &...
273
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
258
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
183
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Romano Surgical Instrumentation, Inc.
Medical Device Manufacturer
·
US , Seattle , WA
Romano Surgical Instrumentation, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1988
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Romano Surgical Instrumentation, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 29, 1989
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
K885229
·
HSZ
Orthopedic
·
294d
Cleared
Mar 25, 1988
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
K880074
·
HSZ
Orthopedic
·
74d
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2
Orthopedic
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