FDA.reportPublic FDA data

Seitz Solution Radial Head Implant System 18 x 9mm Radial Head

Primary DI
B033KCHI18090
Brand
Seitz Solution Radial Head Implant System 18 x 9mm Radial Head
Company
Kapp Surgical Instrument Co.
Model
KCHI-1809
Catalog number
KCHI-1809
Device description
18 x 9mm Radial Head
Published
2023-06-09
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
KWIProsthesis, Elbow, Hemi-, Radial, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030237000KAPP CUSTOM RADIAL HEAD ELBOW IMPLANTKapp Surgical Instrument, Inc.2003-08-29KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B033KCHI18090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(216) 587-4400info@kappsurgical.com

Regulatory Flags#

DUNS number
004171112
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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B033KS9993R1Lateral Tibia Retractor - RightRightKS-9993-R2025-04-15
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B033KS400470Coned Heparin NeedlesKS-4004-7KS-4004-72023-06-14
B033KS400540Coned Heparin NeedlesKS-4005-4KS-4005-42023-06-14
B033KS400570Coned Heparin NeedlesKS-4005-7KS-4005-72023-06-14
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Primary DI, Brand, Company table
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00885556830574PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
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