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Orthodontic Fixation Screw [Smart Anchor Miniscrew]

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191041
510(k) Type
Traditional
Applicant
GNI Co., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
497 days
Submission Type
Summary

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191041
510(k) Type
Traditional
Applicant
GNI Co., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
497 days
Submission Type
Summary