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Nautilus Spinal System

by Life Spine, Inc. 5 variants

510(k) K140457

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK140457 Date25 Mar 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nautilus Spinal System is a thoracolumbar spinal fixation device designed for surgical stabilization of the thoracic and lumbar spine. It includes implants and instruments intended to address spinal pathologies through posterior osteosynthesis, providing structural support and alignment during spinal reconstruction or fusion procedures.

This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in spinal procedures. It is regulated under FDA 510(k) clearance (K140457) as a Special submission under the Orthopedic advisory committee, with no third-party review. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.

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    Class II

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