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FDA 510(k)

Fortilink with TiPlus Technology

K-Number: K213493 · 2022-01-27

ApplicantParadigm Spine
Decision Date2022-01-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink with TiPlus Technology is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Spine. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K213493. 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 with TiPlus Technology?

Fortilink with TiPlus Technology is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Paradigm Spine. The 510(k) number is K213493.

When did Fortilink with TiPlus Technology receive FDA 510(k) clearance?

Fortilink with TiPlus Technology received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213493.

Who is the listed applicant for Fortilink with TiPlus Technology?

The FDA 510(k) record lists Paradigm Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fortilink with TiPlus Technology?

The FDA product code for Fortilink with TiPlus Technology is ODP.

Other records listing Paradigm Spine 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.

K201453Fortilink Cages with TiPlus TechnologyK201704CoFix SystemK153302coflex-IF

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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