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FDA 510(k)

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

K-Number: K132366 · 2013-09-03

ApplicantAccel Spine
Decision Date2013-09-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Accel Spine. It received FDA 510(k) clearance on 2013-09-03 under 510(k) number K132366. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS?

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS is a medical device that received FDA 510(k) clearance on 2013-09-03. The listed applicant is Accel Spine. The 510(k) number is K132366.

When did SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS receive FDA 510(k) clearance?

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS received FDA 510(k) clearance on 2013-09-03, under 510(k) number K132366.

Who is the listed applicant for SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS?

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 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS?

The FDA product code for SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS is KWQ.

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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 SYSTEMK132365SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONK121567ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMK121568DALI SPINAL FIXATION SYSTEMK121078VAN GOGH ANTERIOR CERVICAL PLATE SYSTEMK120714PICASSO MIS SPINAL FIXATION SYSTEM

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Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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