H2 PE INLAY SIZE 5 LEFT 5MM/ANTERIOR
DT MedTech LLC - 1
Device Description
A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HSN
Device Name: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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: 888.3110
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: B095322515
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A