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Single Platform SP1 Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232418
510(k) Type
Traditional
Applicant
Southern Implants (Pty) Ltd
Country
South Africa
FDA Decision
Substantially Equivalent
Decision Date
12/1/2023
Days to Decision
112 days
Submission Type
Summary

Single Platform SP1 Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232418
510(k) Type
Traditional
Applicant
Southern Implants (Pty) Ltd
Country
South Africa
FDA Decision
Substantially Equivalent
Decision Date
12/1/2023
Days to Decision
112 days
Submission Type
Summary