FDA.reportPublic FDA data

Rhausler

Primary DI
08500588270267
Brand
Rhausler
Company
Rhausler Inc.
Model
C-4123
Catalog number
C-4123
Device description
Dynamic Cervical Plate Ti, 23mm, 1LVL
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
08500588270267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500588270267085005882702678500588270267

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
Length23Millimeter

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
08500588270328RhauslerC-4135C-41352024-03-13
08500588270366RhauslerC-4246C-42462024-03-13
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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00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
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00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
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00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28