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FDA 510(k)

Fortilink™-C with TETRAfuse™ 3D Technology

K-Number: K163673 · 2017-05-23

Decision Date2017-05-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink™-C with TETRAfuse™ 3D Technology is a medical device manufactured by Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-05-23 under approval number K163673. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fortilink™-C with TETRAfuse™ 3D Technology?

Fortilink™-C with TETRAfuse™ 3D Technology is a medical device that received FDA 510(k) clearance on 2017-05-23. It is manufactured by Rti Surgical, Inc.. The 510(k) number is K163673.

When was Fortilink™-C with TETRAfuse™ 3D Technology approved by the FDA?

Fortilink™-C with TETRAfuse™ 3D Technology received FDA 510(k) clearance on 2017-05-23, under approval number K163673.

What company makes Fortilink™-C with TETRAfuse™ 3D Technology?

Fortilink™-C with TETRAfuse™ 3D Technology is manufactured by Rti Surgical, Inc..

What is the FDA product code for Fortilink™-C with TETRAfuse™ 3D Technology?

The FDA product code for Fortilink™-C with TETRAfuse™ 3D Technology is ODP.

Other Devices by Rti Surgical, Inc.

Related Devices (Code: ODP)

Official Source

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