Last synced on 19 July 2024 at 11:05 pm

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230036
510(k) Type
Traditional
Applicant
RTI Surgical, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/23/2023
Days to Decision
178 days
Submission Type
Summary

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230036
510(k) Type
Traditional
Applicant
RTI Surgical, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/23/2023
Days to Decision
178 days
Submission Type
Summary