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FDA 510(k)

LANX ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K050774 · 2005-04-11

ApplicantLanx, LLC
Decision Date2005-04-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LANX ANTERIOR CERVICAL PLATE 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 2005-04-11 under 510(k) number K050774. 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 LANX ANTERIOR CERVICAL PLATE SYSTEM?

LANX ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Lanx, LLC. The 510(k) number is K050774.

When did LANX ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

LANX ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050774.

Who is the listed applicant for LANX ANTERIOR CERVICAL PLATE 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 LANX ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for LANX ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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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)K093285MODIFICATION TO LANX SPINAL FIXATION SYSTEMK082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICEK073144LANX INTERVERTEBRAL BODY FUSION DEVICE

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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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