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Prow Fusion-L

by Nlt Spine, Ltd.

510(k) K153665

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 NumberK153665 Date15 Sep 2016ClearedStatusActive

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  • Withdrawn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, 22 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 Prow Fusion-L is an intervertebral body fusion device designed for spinal fusion procedures. It is part of a non-linear technology platform intended to address various spine pathologies.

This device is indicated for use at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease. It has received FDA 510(k) clearance.

Other devices from Nlt Spine, Ltd.

  • Prow Fusion

    Class II

  • Prow Fusion-V

    Class II

  • Espin

    Class II

  • ESPIN System

    Class II

  • Prow Fusion

    Class II

  • Prow Fusion

    Class II

See all devices from Nlt Spine, Ltd. →

Questions

AI-generated answers, 22 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 intended use of the Prow Fusion-L?

    The Prow Fusion-L is an intervertebral body fusion device designed for spinal fusion procedures. It is specifically indicated for use in skeletally mature patients diagnosed with degenerative disc disease at one or two contiguous levels from L2 through S1.

  • What is the regulatory status of this device?

    The Prow Fusion-L has received FDA 510(k) clearance. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for the purposes of its intended use.

  • What technology platform does the Prow Fusion-L utilize?

    This device is part of a non-linear technology platform developed by Nlt Spine, Ltd. This platform is intended to address various spine pathologies through the application of the Prow Fusion-L system.