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FDA 510(k)

ORTHOPEDIC ALLIANCE SPINE SYSTEM

K-Number: K033826 · 2004-07-01

ApplicantOrthopedic Alliance, LLC
Decision Date2004-07-01
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC ALLIANCE SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Alliance, LLC. It received FDA 510(k) clearance on 2004-07-01 under 510(k) number K033826. 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 ORTHOPEDIC ALLIANCE SPINE SYSTEM?

ORTHOPEDIC ALLIANCE SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Orthopedic Alliance, LLC. The 510(k) number is K033826.

When did ORTHOPEDIC ALLIANCE SPINE SYSTEM receive FDA 510(k) clearance?

ORTHOPEDIC ALLIANCE SPINE SYSTEM received FDA 510(k) clearance on 2004-07-01, under 510(k) number K033826.

Who is the listed applicant for ORTHOPEDIC ALLIANCE SPINE SYSTEM?

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

What is the FDA product code for ORTHOPEDIC ALLIANCE SPINE SYSTEM?

The FDA product code for ORTHOPEDIC ALLIANCE SPINE SYSTEM is MNI.

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.

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Other records listing Orthopedic Alliance, LLC 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.

K052237SC CERAMIC BALL HEADSK031474SC TOTAL HIP SYSTEM

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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