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Internal Hex Implant System

Page Type
Cleared 510(K)
510(k) Number
K190837
510(k) Type
Traditional
Applicant
EBI Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2020
Days to Decision
296 days
Submission Type
Summary

Internal Hex Implant System

Page Type
Cleared 510(K)
510(k) Number
K190837
510(k) Type
Traditional
Applicant
EBI Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2020
Days to Decision
296 days
Submission Type
Summary