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AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213110
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
12/16/2022
Days to Decision
448 days
Submission Type
Summary

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213110
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
12/16/2022
Days to Decision
448 days
Submission Type
Summary