510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1464
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1920
General Hospital
1456
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
826
Obstetrics & Gynecology
364
Ophthalmic
245
Orthopedic
2516
Pathology
49
Physical Medicine
444
Radiology
2084
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
248
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Sutter Corp.
Medical Device Manufacturer
·
US , San Diego , CA
Sutter Corp. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1989
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sutter Corp.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 12, 1995
SUTTER HAMMERTOE JOINT PROSTHESIS
K943354
·
KWH
Orthopedic
·
335d
Cleared
Mar 10, 1994
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K931588
·
KYJ
Orthopedic
·
344d
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7
Physical Medicine
5
Orthopedic
2