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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
OEW
Tracking, Soft Tissue, Intraoperative
2
Product Code
ONA
Computer Assisted Hair Harvesting System
2
Product Code
K
17
3358
ARTAS System
2
Cleared 510(K)
K
12
3548
THE ARTAS SYSTEM
2
Cleared 510(K)
K
12
3154
ARTAS SYSTEM FROM RESTORATION ROBOTICS
2
Cleared 510(K)
K
10
3428
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
2
Cleared 510(K)
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
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Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-e—neurological-surgical-devices
/
ONA
/
K103428
View Source
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103428
510(k) Type
Traditional
Applicant
RESTORATION ROBOTICS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/4/2011
Days to Decision
133 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
OEW
Tracking, Soft Tissue, Intraoperative
ONA
Computer Assisted Hair Harvesting System
K
17
3358
ARTAS System
K
12
3548
THE ARTAS SYSTEM
K
12
3154
ARTAS SYSTEM FROM RESTORATION ROBOTICS
K
10
3428
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-e—neurological-surgical-devices
/
ONA
/
K103428
View Source
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103428
510(k) Type
Traditional
Applicant
RESTORATION ROBOTICS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/4/2011
Days to Decision
133 days
Submission Type
Summary