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FDA 510(k)

Calix-C Cervical Interbody Spacer

K-Number: K171075 · 2017-08-01

ApplicantX-Spine Systems, Inc.
Decision Date2017-08-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Calix-C Cervical Interbody Spacer is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171075. 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 Calix-C Cervical Interbody Spacer?

Calix-C Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K171075.

When did Calix-C Cervical Interbody Spacer receive FDA 510(k) clearance?

Calix-C Cervical Interbody Spacer received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171075.

Who is the listed applicant for Calix-C Cervical Interbody Spacer?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Calix-C Cervical Interbody Spacer?

The FDA product code for Calix-C Cervical Interbody Spacer is ODP.

Other records listing X-Spine Systems, Inc. as applicant

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K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK170224Spider Cervical Plating SystemK170530Butrex Lumbar Buttress Plating System

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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

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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