Seitz Solution Unlar Head

Primary DI
B033KCUH1617
Brand
Seitz Solution Unlar Head
Company
Kapp Surgical Instrument Co.
Model
KCUH-1617
Catalog number
KCUH-1617
Device description
16.5x17mm Ulnar Head
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXEProsthesis, Wrist, Hemi-, Ulnar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXEProsthesis, Wrist, Hemi-, UlnarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033930000KAPP CUSTOM ULNAR HEAD WRIST IMPLANTKapp Surgical Instrument, Inc.2004-07-28KXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B033KCUH1617PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wrist ulna-head prosthesisA sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or 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

Regulatory Flags#

DUNS number
004171112
Device count
1
Lot or batch
true
Sterilization required before use
true

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B033KS400540Coned Heparin NeedlesKS-4005-4KS-4005-42023-06-14
B033KS400570Coned Heparin NeedlesKS-4005-7KS-4005-72023-06-14
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B033KS400670Coned Heparin NeedlesKS-4006-7KS-4006-72023-06-14
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885556826485First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826492First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826508First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826515First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826522First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826539First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826546First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826553First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
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00885556826195First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826201First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826218First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826225First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826232First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826249First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826256First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
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B013DRUJB10200NAAPTIS MEDICAL, LLCKXE2021-08-27