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FDA 510(k)

LANX VBR SYSTEM

K-Number: K052384 · 2005-10-07

ApplicantLanx, LLC
Decision Date2005-10-07
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LANX VBR 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 2005-10-07 under 510(k) number K052384. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANX VBR SYSTEM?

LANX VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Lanx, LLC. The 510(k) number is K052384.

When did LANX VBR SYSTEM receive FDA 510(k) clearance?

LANX VBR SYSTEM received FDA 510(k) clearance on 2005-10-07, under 510(k) number K052384.

Who is the listed applicant for LANX VBR 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 VBR SYSTEM?

The FDA product code for LANX VBR SYSTEM is MQP.

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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: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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