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ACR Screw System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222245
510(k) Type
Traditional
Applicant
BioMaterials Korea, Inc
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/21/2023
Days to Decision
391 days
Submission Type
Summary

ACR Screw System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222245
510(k) Type
Traditional
Applicant
BioMaterials Korea, Inc
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/21/2023
Days to Decision
391 days
Submission Type
Summary