510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
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466
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965
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433
Ophthalmic
274
Orthopedic
2900
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52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Orthosoft Inc. (d/b/a) Zimmer CAS
Medical Device Manufacturer
·
CA , Montreal
Orthosoft Inc. (d/b/a) Zimmer CAS - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 2017
Official Website
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthosoft Inc. (d/b/a) Zimmer CAS
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 23, 2023
ROSA Hip System
K231162
·
LLZ
Radiology
·
29d
Cleared
Aug 23, 2019
Efficient Care 3D Planning
K183544
·
LLZ
Radiology
·
246d
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18
Orthopedic
16
Radiology
2