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FDA 510(k)

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

K-Number: K132365 · 2013-08-20

ApplicantAccel Spine
Decision Date2013-08-20
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Accel Spine. It received FDA 510(k) clearance on 2013-08-20 under 510(k) number K132365. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION?

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Accel Spine. The 510(k) number is K132365.

When did SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION receive FDA 510(k) clearance?

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION received FDA 510(k) clearance on 2013-08-20, under 510(k) number K132365.

Who is the listed applicant for SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION?

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 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION?

The FDA product code for SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION is MNI.

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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 ORTHOSISK121567ORACLE 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: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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