Elegance® Anterior Cervical Plate 53044014

by Clariance, Inc.

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	Number03700780644872 UDI-DI	Date22 Jan 2025Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-1821-2026 FDA Class II initiated 20 Feb 2026
Due to a quality issue regarding the presence of burr on the finished cervical plate product.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Elegance® Anterior Cervical Plate
Generic Name: Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog: 53044014

Primary DI / UDI-DI: 03700780644872
510(k) Number: K243904
FDA Product Code: KWQ
GMDN Term: Spinal bone screw, non-bioabsorbable

Device Class: Class II
Regulation Number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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See all devices from Clariance, Inc. →

Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: 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