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Espin

by Nlt Spine, Ltd. 2 variants

510(k) K120553

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 NumberK120553 Date9 Aug 2012ClearedStatusActive

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  • Withdrawn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 an orthopedic device, classified under the product code HRX. It is substantially equivalent and has a traditional clearance type.

The Espin is supplied by Nlt Spine, Ltd. and has been authorized with FDA 510K clearance. The device has a specific k number, K120553, and is associated with the advisory committee OR.

Other devices from Nlt Spine, Ltd.

  • Prow Fusion-L

    Class II

  • Prow Fusion

    Class II

  • Prow Fusion-V

    Class II

  • Espin

    Class II

  • ESPIN System

    Class II

  • Prow Fusion

    Class II

See all devices from Nlt Spine, Ltd. →

Questions

AI-generated answers, 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.

  • What is the Espin device used for?

    The Espin is an orthopedic device, indicating its use in orthopedic applications, but specific indications are not provided.

  • How is the Espin device supplied?

    The Espin is supplied by Nlt Spine, Ltd., the manufacturer, but details on packaging or distribution are not specified.

  • Is the Espin device sterile?

    Sterility information is not provided in the available data, so it's unclear if the Espin is supplied sterile or must be sterilized before use.

  • What is the regulatory status of the Espin device?

    The Espin has been authorized with FDA 510K clearance, indicating it is substantially equivalent to a predicate device and has undergone a traditional clearance process.