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FDA 510(k)

Fortilink™-C with TETRAfuse™ 3D Technology

K-Number: K163673 · 2017-05-23

ApplicantRti Surgical, Inc.
Decision Date2017-05-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink™-C with TETRAfuse™ 3D Technology is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) 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. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K163673.

When did Fortilink™-C with TETRAfuse™ 3D Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for Fortilink™-C with TETRAfuse™ 3D Technology?

The FDA 510(k) record lists Rti Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Rti Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253145Pre-Sutured TendonK241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCK230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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.

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