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FDA 510(k)

SPINAL FIXATION SYSTEM

K-Number: K092536 · 2009-10-30

ApplicantLanx, Inc.
Decision Date2009-10-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lanx, Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K092536. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL FIXATION SYSTEM?

SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Lanx, Inc.. The 510(k) number is K092536.

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

SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2009-10-30, under 510(k) number K092536.

Who is the listed applicant for SPINAL FIXATION SYSTEM?

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

What is the FDA product code for SPINAL FIXATION SYSTEM?

The FDA product code for SPINAL FIXATION SYSTEM is NKB.

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Other records listing Lanx, Inc. 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.

K131547LANX FUSION SYSTEMK131156LANX SPINAL FIXATION SYSTEMK123767LANX FUSION SYSTEM- SAK121316LANX SPINAL FIZATION SYSTEMK122145LANX SPINAL FIXATION SYSTEMK121940LANX SPINAL FIXATION SYSTEM

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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