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Lotus

by Spinal Elements, Inc.

510(k) K131427

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 · Traditional NumberK131427 Date24 Oct 2013ClearedStatusActive

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  • Withdrawn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
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
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

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

Overview

AI-generated summary, 20 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 Lotus is a posterior cervical-thoracic fixation system, classified as a spinal fixation device. It is designed to provide secure stabilization of the cervical and upper thoracic spine through pedicle screw and rod constructs, facilitating surgical interventions such as minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).

The system is supplied as a reusable surgical implant, featuring a 3.5 mm rod with anatomically accurate, pre-cut and pre-lordosed configurations. It is intended for use in orthopedic settings and has received FDA 510(k) clearance under the Traditional pathway, with a clearance date of October 24, 2013. The device is manufactured by Spinal Elements, Inc., and is categorized under the product code KWP for orthopedic applications.

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