- Physicians Office Resource

TRIAL 9500830 08MMX30MM STR
Crescent Spinal System Titanium - 9500830

Device Description

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

Product Codes

Code: MAX

Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar

Device Class: 2

Physical State: hollow cylinder or rectangular box made of metal or polymer

Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Acts as a disc spacer and holds bone graft.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: intervertebral disc space

Regulation Number: 888.3080

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00613994907851

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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