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FDA 510(k)

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

K-Number: K230036 · 2023-06-23

ApplicantRti Surgical, Inc.
Decision Date2023-06-23
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is a medical device manufactured by Rti Surgical, Inc.. It received FDA 510(k) clearance on 2023-06-23 under approval number K230036. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Rti Surgical, Inc.. The 510(k) number is K230036.

When was Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) approved by the FDA?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) received FDA 510(k) clearance on 2023-06-23, under approval number K230036.

What company makes Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is manufactured by Rti Surgical, Inc..

What is the FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

The FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is GAT.

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Other Devices by Rti Surgical, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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