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Osteon Precision Milled Suprastructure

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221019
510(k) Type
Traditional
Applicant
Implant Solutions PTY LTD (aka Osteon Medical)
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
7/5/2022
Days to Decision
90 days
Submission Type
Summary

Osteon Precision Milled Suprastructure

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221019
510(k) Type
Traditional
Applicant
Implant Solutions PTY LTD (aka Osteon Medical)
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
7/5/2022
Days to Decision
90 days
Submission Type
Summary