Elegance® Anterior Cervical Plate 53044516

by Clariance, Inc. GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03700780644926 UDI-DI	Date22 Jan 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

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.

Specification

GUDID

Trade Name: Elegance® Anterior Cervical Plate
Generic Name: Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog: 53044516

Primary DI / UDI-DI: 03700780644926
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