SPACER 6671236 CRESCENT TI
CRESCENT™ Spinal System - 6671236
Device Description
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 12.0 Millimeter
- Height: 36.0 Millimeter
- Angle: 6.0 degree
- Width: 12.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
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 IdentifiersDevice Id: 00613994523358
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