Seitz Solution Unlar Head

Basic Information

• Brand Name: Seitz Solution Unlar Head
• Primary DI: B033KCUH1314
• Version / Model: KCUH-1314
• Catalog Number: KCUH-1314
• Company Name: Kapp Surgical Instrument Co.
• Labeler DUNS: 004171112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d4590bc5-926e-4737-ab34-f51edb0d646e

Device Description

13.5x14mm Ulnar Head

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	888.3810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33720	Wrist ulna-head prosthesis	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B033KCUH1314	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K033930	000