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FDA 510(k)

MODIFICATION TO LANX SPINAL FIXATION SYSTEM

K-Number: K093285 · 2009-12-10

ApplicantLanx, LLC
Decision Date2009-12-10
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LANX SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lanx, LLC. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K093285. 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 MODIFICATION TO LANX SPINAL FIXATION SYSTEM?

MODIFICATION TO LANX SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Lanx, LLC. The 510(k) number is K093285.

When did MODIFICATION TO LANX SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO LANX SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2009-12-10, under 510(k) number K093285.

Who is the listed applicant for MODIFICATION TO LANX SPINAL FIXATION SYSTEM?

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

What is the FDA product code for MODIFICATION TO LANX SPINAL FIXATION SYSTEM?

The FDA product code for MODIFICATION TO LANX SPINAL FIXATION SYSTEM is MNI.

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Other records listing Lanx, 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.

K120399LANX SPINAL FIXATION SYSTEMK102738LANX FUSION SYSTEMK103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)K082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICEK073144LANX INTERVERTEBRAL BODY FUSION DEVICEK071905POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

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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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