510k
Database
Specialties
Anesthesiology
441
Cardiovascular
1343
Chemistry
331
Dental
1037
Ear, Nose, Throat
193
Gastroenterology & Urology
796
General & Plastic Surgery
1759
General Hospital
1174
Hematology
119
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
753
Obstetrics & Gynecology
331
Ophthalmic
205
Orthopedic
2404
Pathology
44
Physical Medicine
402
Radiology
1945
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
250
QIH
Automated Radiological Image...
248
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
235
OLO
Orthopedic Stereotaxic Instrument
198
LZA
Polymer Patient Examination Glove
193
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
166
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Plus Orthopedics AG
Medical Device Manufacturer
·
US , Norfolk , MA
Plus Orthopedics AG - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2006
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Plus Orthopedics AG
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 31, 2007
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K070731
·
HAW
Neurology
·
138d
Cleared
Oct 06, 2006
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
K061362
·
HAW
Neurology
·
143d
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5
Orthopedic
3
Neurology
2