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Espin

by Nlt Spine, Ltd. 2 variants

510(k) K130057

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 · Special NumberK130057 Date7 Feb 2013ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Espin is a discectomy system designed for use in spinal surgical procedures. It is categorized as an orthopedic device intended to assist in the performance of discectomy.

This device is cleared through the FDA 510(k) pathway under K130057. It is manufactured by Nlt Spine, Ltd. and is classified as a Class 2 orthopedic device.

Other devices from Nlt Spine, Ltd.

  • Prow Fusion-L

    Class II

  • Prow Fusion

    Class II

  • Prow Fusion-V

    Class II

  • ESPIN System

    Class II

  • Espin

    Class II

  • Prow Fusion

    Class II

See all devices from Nlt Spine, Ltd. →