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Mountaineer Laminoplasty System

by Depuy Spine, Inc.

510(k) K091994

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 NumberK091994 Date7 Jan 2010ClearedStatusActive

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  • Withdrawn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
NQW
Device Class
Class II
Regulation
21 CFR Part 888.3050
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 Mountaineer Laminoplasty System is a complete set of implants and instruments designed for laminoplasty procedures in the cervical spine. It is classified as an Orthosis, Spine, Plate, Laminoplasty, Metal under FDA device classification.

The system is intended for use in the lower cervical and upper thoracic spine (C3 to T3) to hold or buttress allograft or autograft material in place, preventing expulsion or impingement of the spinal cord. It is supplied as a non-sterile, reusable system and has received FDA 510(k) clearance under K091994 with product code NQW and regulation number 888.3050.

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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 Mountaineer Laminoplasty System used for?

    The Mountaineer Laminoplasty System is designed for laminoplasty procedures in the cervical spine, specifically to hold or buttress allograft or autograft material in place from C3 to T3, preventing expulsion or impingement of the spinal cord.

  • Is the Mountaineer Laminoplasty System sterile or non-sterile, and is it reusable?

    The system is supplied as a non-sterile, reusable system, meaning it must be sterilized by the user before each use and can be reprocessed for multiple procedures following appropriate cleaning and sterilization protocols.

  • What spinal levels is the Mountaineer Laminoplasty System intended for?

    The system is intended for use in the lower cervical and upper thoracic spine, specifically from the C3 vertebra to the T3 vertebra, to support laminoplasty procedures in that anatomical range.

  • What type of device is the Mountaineer Laminoplasty System classified as under FDA regulations?

    The Mountaineer Laminoplasty System is classified as an Orthosis, Spine, Plate, Laminoplasty, Metal under FDA device classification, with product code NQW and regulation number 888.3050.

  • What is the FDA authorization pathway for the Mountaineer Laminoplasty System?

    The Mountaineer Laminoplasty System received FDA 510(k) clearance under submission number K091994, indicating it was found substantially equivalent to a legally marketed predicate device.