510k
Database
Specialties
Anesthesiology
438
Cardiovascular
1336
Chemistry
330
Dental
1033
Ear, Nose, Throat
192
Gastroenterology & Urology
795
General & Plastic Surgery
1754
General Hospital
1160
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
747
Obstetrics & Gynecology
329
Ophthalmic
204
Orthopedic
2396
Pathology
44
Physical Medicine
400
Radiology
1937
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
286
LLZ
System, Image Processing,...
276
GEI
Electrosurgical, Cutting &...
248
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
188
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Arc Surgical, LLC
Medical Device Manufacturer
·
US , Hillsboro , OR
Arc Surgical, LLC - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2005
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arc Surgical, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 19, 2007
ARC SURGICAL BIOTRAK PIN SYSTEM
K071616
·
HTY
Orthopedic
·
189d
Cleared
Dec 27, 2006
ARC SURGICAL BONE REDUCTION SCREW
K063244
·
HWC
Orthopedic
·
62d
Cleared
Sep 19, 2006
ARC SURGICAL BIOTRAK SCREW
K061763
·
HWC
Orthopedic
·
89d
Cleared
Jun 17, 2005
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
K043176
·
HWC
Orthopedic
·
213d
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5
Orthopedic
4
Neurology
1