Sigmoid Notch Screw
NA - 390-0222
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Length: 24.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KXE
Device Name: Prosthesis, Wrist, Hemi-, Ulnar
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3810
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00886385022321
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A