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FDA 510(k)

MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM

K-Number: K121569 · 2012-07-27

ApplicantAccel Spine
Decision Date2012-07-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accel Spine. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K121569. 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 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM?

MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Accel Spine. The 510(k) number is K121569.

When did MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM receive FDA 510(k) clearance?

MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM received FDA 510(k) clearance on 2012-07-27, under 510(k) number K121569.

Who is the listed applicant for MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM?

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

What is the FDA product code for MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM?

The FDA product code for MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM is ODP.

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Other records listing Accel 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.

K131981CEZANNE II INTERBODY FUSION SYSTEMK132366SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSISK132365SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONK121567ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMK121568DALI SPINAL FIXATION SYSTEMK121078VAN GOGH ANTERIOR CERVICAL PLATE 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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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.

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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