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Elegance® Anterior Cervical Plate 98706009

by Clariance, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K243904; other models may be affected

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700780654529 UDI-DI Date12 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1821-2026 FDA Class II initiated 20 Feb 2026 on shared 510(k) K243904

    Due to a quality issue regarding the presence of burr on the finished cervical plate product.

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Elegance® Anterior Cervical Plate
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
98706009
Primary DI / UDI-DI
03700780654529
510(k) Number
FDA Product Code
LXH
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243904)

Show all (12)

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: 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