Elegance® Anterior Cervical plate— 510(k) K243904

Name: FDA 510(k) clearance K243904
Creator: U.S. Food and Drug Administration
Published: 2025-01-14

Substantially Equivalent

Clariance

FDA 510(k) clearance K243904 for Elegance® Anterior Cervical plate, Substantially Equivalent on 2025-01-14. Applicant: Clariance. Device class: 2.

Clearance details

Applicant: Clariance
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2024-12-19
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaurains, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Clariance

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K243670 — Idys® LIF2024-12-31
K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS2024-07-24
K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System2024-04-26
K240715 — Idys® C ZP 3DTi2024-03-22
K220182 — Aggeris-C2022-03-30

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K243904

K-number listed on FDA's recall record

Z-1821-2026 — Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.Class II·Ongoing·Clariance-SAS·20260220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243904.

Data sourced from openFDA. This site is unofficial and independent of the FDA.