FDA.reportPublic FDA data

Elegance® Anterior Cervical Plate

Primary DI
03700780644308
Brand
Elegance® Anterior Cervical Plate
Company
CLARIANCE
Model
53706001
Catalog number
53706001
Device description
FIXED DRILL-GUIDE
Published
2025-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243904000Elegance® Anterior Cervical plateClariance2025-01-14KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700780644308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780644308037007806443083700780644308

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 773 868 7041s.chambat@clariance-spine.us

Regulatory Flags#

DUNS number
296568400
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700780640195Idys®-ALIF ZP 3DTi45721000457210002026-07-28
03700780654611Idys®-ALIF ZP 3DTi45710003457100032026-07-28
03700780634583Erisma®-LP18710039187100392026-05-28
03700780643554Erisma®-LP15742006157420062026-02-26
03700780600120Idys™- LIF04522008-S04522008-S2015-10-22
03700780600137Idys™- LIF04522009-S04522009-S2015-10-22
03700780600168Idys™- LIF04522012-S04522012-S2015-10-22
03700780600175Idys™- LIF04522013-S04522013-S2015-10-22
03700780600182Idys™- LIF04522508-S04522508-S2015-10-22
03700780600199Idys™- LIF04522509-S04522509-S2015-10-22
03700780600212Idys™- LIF04522011-S04522011-S2015-10-22
03700780600229Idys™- LIF04522512-S04522512-S2015-10-22
03700780600243Idys™- LIF04522514-S04522514-S2015-10-22
03700780600267Idys™- LIF04522809-S04522809-S2015-10-22
03700780600274Idys™- LIF04522810-S04522810-S2015-10-22
03700780600281Idys™- LIF04522811-S04522811-S2015-10-22
03700780600298Idys™- LIF04522812-S04522812-S2015-10-22
03700780600311Idys™- LIF04522814-S04522814-S2015-10-23
03700780600335Idys™- LIF04523209-S04523209-S2015-10-23
03700780600342Idys™- LIF04523210-S04523210-S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
00840606174923PrimusSPINAL ELEMENTS, INC.LXH2026-09-22
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685231490Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685283430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7682460370Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-09-24
B7682440010Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-06-20
B7682459240Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682460080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682459260Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B768345211500Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685118310Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685211080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685215150Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685271430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27