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FDA 510(k)

NAUTILUS SPINAL SYSTEM

K-Number: K132866 · 2013-10-28

ApplicantLife Spine, Inc.
Decision Date2013-10-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NAUTILUS SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2013-10-28 under 510(k) number K132866. 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 NAUTILUS SPINAL SYSTEM?

NAUTILUS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-28. The listed applicant is Life Spine, Inc.. The 510(k) number is K132866.

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

NAUTILUS SPINAL SYSTEM received FDA 510(k) clearance on 2013-10-28, under 510(k) number K132866.

Who is the listed applicant for NAUTILUS SPINAL SYSTEM?

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

What is the FDA product code for NAUTILUS SPINAL SYSTEM?

The FDA product code for NAUTILUS SPINAL SYSTEM is NKB.

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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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