- Physicians Office Resource

Sliding Core, UHMPWE, 8mm
STAR - 400-142F

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

Special Storage Condition, Specify

Avoid exposure to direct sunlight or dampness

Storage Environment Humidity - Percent (%) Relative Humidity

70.00
50.00

Storage Environment Temperature - Degrees Celsius

20.00
18.00

Device Sizes

Height: 8 Millimeter

Height: 8 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NTG

Device Name: Prosthesis, Ankle, Uncemented, Non-Constrained

Device Class: 3

Physical State: N/A

Definition: An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.

Submission Type ID: 2

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00886385026947

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

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