FDA.reportPublic FDA data

Rhausler

Primary DI
08500588270366
Brand
Rhausler
Company
Rhausler Inc.
Model
C-4246
Catalog number
C-4246
Device description
Dynamic Cervical Plate Ti, 46mm, 2LVL
Published
2024-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042073000OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMOlsen Medical2005-02-07KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08500588270366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500588270366085005882703668500588270366

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length46Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015811277
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500588270045RhauslerC-3127C-31272024-03-13
08500588270106RhauslerC-3240C-32402024-03-13
08500588270113RhauslerC-3243C-32432024-03-13
08500588270120RhauslerC-3246C-32462024-03-13
08500588270175RhauslerC-3357C-33572024-03-13
08500588270250RhauslerC-4121C-41212024-03-13
08500588270267RhauslerC-4123C-41232024-03-13
08500588270328RhauslerC-4135C-41352024-03-13
08500588270441RhauslerC-4366C-43662024-03-13
08500588270489RhauslerC-4378C-43782024-03-13
08500588270595RhauslerC-4509C-45092024-03-13
08500588270663RhauslerC-5133C-51332024-03-13
08500588270687RhauslerC-5237C-52372024-03-13
08500588270717RhauslerC-5246C-52462024-03-13
08500588270731RhauslerC-5252C-52522024-03-13
08500588270755RhauslerC-5354C-53542024-03-13
08500588270762RhauslerC-5357C-53572024-03-13
08500588270793RhauslerC-5366C-53662024-03-13
08500588270946RhauslerC-5509C-55092024-03-13
08500588270960RhauslerC-6010C-60102024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00810056995638corraCarlsmed, Inc.KWQ2026-08-17
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00193982673499CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
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00193982673529CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673536CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673550CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673567CREOGLOBUS MEDICAL, INC.KWQ2026-08-14