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TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011007
510(k) Type
Traditional
Applicant
ARTHREX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2001
Days to Decision
69 days
Submission Type
Summary

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011007
510(k) Type
Traditional
Applicant
ARTHREX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2001
Days to Decision
69 days
Submission Type
Summary