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Cogent Med-LIF

by Cogent Spine, LLC

510(k) K132738

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132738 Date15 Apr 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Cogent Med-LIF is an intervertebral fusion device with bone graft, lumbar, classified under the MAX product code for intervertebral fusion devices and spinal implants. It is a Class II medical device subject to special controls.

It is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The device received FDA 510(k) clearance (K132738) on April 15, 2014, and is substantially equivalent to legally marketed predicates.

Other devices from Cogent Spine, LLC

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Cogent Med-LIF used for?

    The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous lumbar levels from L2 to S1. It is designed as an intervertebral fusion device to support spinal stabilization and promote bone growth between vertebrae in the lumbar spine.

  • How is the Cogent Med-LIF supplied and is it sterile?

    The device data does not specify whether the Cogent Med-LIF is supplied sterile or non-sterile, or details about its packaging and sterilization method. This information would typically be found in the device’s labeling or instructions for use, which are not included in the provided data.

  • Is the Cogent Med-LIF a single-use or reusable device?

    The provided device data does not indicate whether the Cogent Med-LIF is intended for single-use or reuse. Determination of reusability depends on the device’s design, materials, and manufacturer’s instructions, which are not detailed in the authorization summary.

  • What sizes or models are available for the Cogent Med-LIF?

    The device data does not list specific sizes, models, or reference numbers for the Cogent Med-LIF beyond the product name and K132738 clearance identifier. Size options (e.g., footprint, height, lordosis) would be defined in the device’s technical specifications or labeling, which are not included here.

  • What regulatory pathway was used for the Cogent Med-LIF?

    The Cogent Med-LIF received FDA 510(k) clearance under submission K132738, determined to be substantially equivalent to legally marketed predicate devices. It is classified as a Class II medical device under product code MAX for intervertebral fusion devices and spinal implants, subject to special controls.