FDA 510(k)

ReConnex Pre-Sutured Tendon

K-Number: K170957 · 2018-03-20

Decision Date2018-03-20

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ReConnex Pre-Sutured Tendon is a medical device manufactured by Allosource. It received FDA 510(k) clearance on 2018-03-20 under approval number K170957. 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 ReConnex Pre-Sutured Tendon?

ReConnex Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2018-03-20. It is manufactured by Allosource. The 510(k) number is K170957.

When was ReConnex Pre-Sutured Tendon approved by the FDA?

ReConnex Pre-Sutured Tendon received FDA 510(k) clearance on 2018-03-20, under approval number K170957.

What company makes ReConnex Pre-Sutured Tendon?

ReConnex Pre-Sutured Tendon is manufactured by Allosource.

What is the FDA product code for ReConnex Pre-Sutured Tendon?

The FDA product code for ReConnex Pre-Sutured Tendon is GAT.

Other Devices by Allosource

K213046AceConnex Pre-Sutured Fascia

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Official Source

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