510k
Database
Specialties
Anesthesiology
411
Cardiovascular
1252
Chemistry
309
Dental
950
Ear, Nose, Throat
181
Gastroenterology & Urology
739
General & Plastic Surgery
1606
General Hospital
995
Hematology
113
Immunology
80
Medical Genetics
6
Microbiology
402
Neurology
695
Obstetrics & Gynecology
303
Ophthalmic
186
Orthopedic
2263
Pathology
43
Physical Medicine
378
Radiology
1825
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
267
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
237
IYN
System, Imaging, Pulsed Doppler,...
225
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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Signature Orthopaedics Pty Limited
Medical Device Manufacturer
·
AU , Nsw
Signature Orthopaedics Pty Limited - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2014
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Signature Orthopaedics Pty Limited
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 22, 2014
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP...
K133370
·
LPH
Orthopedic
·
260d
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Orthopedic
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