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Simplify Cervical Artificial Disc

by Nuvasive, Inc.

PMA P200022510(k) K211757

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P200022; other models may be affected

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211757 Date20 Aug 2021ClearedStatusActive
United StatesFDA PMA PMA NumberP200022 Date18 Sep 2020ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1453-2022 FDA Class II initiated 20 Jun 2022 on shared PMA P200022

    Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Full name
Simplify Disc
Trade Name
Simplify® Cervical Artificial Disc
Generic Name
Prosthesis, intervertebral disc
PMA Number
510(k) Number
FDA Product Code
QLQ
Device Class
Class II
Regulation
21 CFR Part 888.4515
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Simplify Cervical Artificial Disc is an intervertebral disc prosthesis designed for the reconstruction of the disc at one level from C3-C7. It is indicated for skeletally mature patients following a single-level discectomy for intractable radiculopathy or myelopathy caused by conditions such as herniated nucleus pulposus, spondylosis, or loss of disc height.

This device is implanted via an open anterior approach in patients who have failed at least six weeks of non-operative treatment or exhibit progressive symptoms. The Simplify Cervical Artificial Disc has received FDA PMA and 510(k) authorizations. It is intended for use in patients with abnormalities localized to the disc space as confirmed by radiographic imaging.

Other devices from Nuvasive, Inc.

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Questions

AI-generated answers, 18 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 Simplify Cervical Artificial Disc used for?

    It is an intervertebral disc prosthesis used for the reconstruction of the disc at one level from C3-C7 in skeletally mature patients suffering from intractable radiculopathy or myelopathy.

  • Who is a candidate for this cervical disc?

    Candidates are skeletally mature patients who have failed at least six weeks of non-operative treatment or who have progressive symptoms, with conditions confirmed by radiographic imaging such as herniated nucleus pulposus or spondylosis.

  • How is the Simplify Cervical Artificial Disc implanted?

    The device is implanted by a surgeon using an open anterior approach to the cervical spine.