FDA 510(k)

FIX-C PEEK Anterior Cervical Interbody System

K-Number: K212266 · 2021-12-21

Decision Date2021-12-21

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FIX-C PEEK Anterior Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212266. 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 FIX-C PEEK Anterior Cervical Interbody System?

FIX-C PEEK Anterior Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Jeil Medical Corporation. The 510(k) number is K212266.

When did FIX-C PEEK Anterior Cervical Interbody System receive FDA 510(k) clearance?

FIX-C PEEK Anterior Cervical Interbody System received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212266.

Who is the listed applicant for FIX-C PEEK Anterior Cervical Interbody System?

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

What is the FDA product code for FIX-C PEEK Anterior Cervical Interbody System?

The FDA product code for FIX-C PEEK Anterior Cervical Interbody System is ODP.

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Other records listing Jeil Medical Corporation as applicant

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Related Devices (Code: ODP)

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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX 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.