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FDA 510(k)

Ayers Rock Cervical interbody fusion system

K-Number: K162694 · 2017-01-12

ApplicantSpineway
Decision Date2017-01-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ayers Rock Cervical interbody fusion system is the device name listed in this FDA 510(k) record. The listed applicant is Spineway. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162694. 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 Ayers Rock Cervical interbody fusion system?

Ayers Rock Cervical interbody fusion system is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Spineway. The 510(k) number is K162694.

When did Ayers Rock Cervical interbody fusion system receive FDA 510(k) clearance?

Ayers Rock Cervical interbody fusion system received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162694.

Who is the listed applicant for Ayers Rock Cervical interbody fusion system?

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

What is the FDA product code for Ayers Rock Cervical interbody fusion system?

The FDA product code for Ayers Rock Cervical interbody fusion system is ODP.

Related Clinical Trials

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Spineway 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.

K231658VEOS Spinal Fixation SystemK191726mont blanc & mont blanc MIS Spinal SystemsK161387Mont Blanc and Mont Blanc MIS Spinal Systems

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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