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Osseointegrated Fixtures

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161548
510(k) Type
Traditional
Applicant
SOUTHERN IMPLANTS (PTY) LTD.
Country
South Africa
FDA Decision
Substantially Equivalent
Decision Date
12/1/2016
Days to Decision
181 days
Submission Type
Summary

Osseointegrated Fixtures

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161548
510(k) Type
Traditional
Applicant
SOUTHERN IMPLANTS (PTY) LTD.
Country
South Africa
FDA Decision
Substantially Equivalent
Decision Date
12/1/2016
Days to Decision
181 days
Submission Type
Summary