Simplify CR-H

by NuVasive, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00843285101013 UDI-DI	Date24 Apr 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-1453-2022 FDA Class II initiated 20 Jun 2022
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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Simplify
Generic Name: Orthopaedic inorganic implant inserter/extractor, reusable
Model / Reference: CR-H

Primary DI / UDI-DI: 00843285101013
PMA Number: P200022
FDA Product Code: MJO
GMDN Term: Orthopaedic inorganic implant inserter/extractor, reusable

Device Class: Class III
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No