PLATE 8967144 PLATE 44MM
XANTUS® Anterior Lateral Supplemental Fixation System - 8967144
Device Description
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
Environmental Conditions
No Data Available
Device Sizes
- 44mm
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: MNH
Device Name: Orthosis, Spondylolisthesis Spinal Fixation
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: 888.3070
Third Party Flag: N
Medical Specialty: OR
Code: KWP
Device Name: Appliance, Fixation, Spinal Interlaminal
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: 888.3050
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00721902214691
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