ANCHOR PLATE,LOCKING,STRAIGHT,LONG
SMARTLOCK - 55-05161
Device Description
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.
Environmental Conditions
No Data Available
Device Sizes
- Number of Screw Holes: 3.0 Holes
- Bar Length: 11.0 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: DZE
Device Name: Implant, Endosseous, Root-Form
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: DE
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: 872.3640
Third Party Flag: N
Medical Specialty: DE
Device IdentifiersDevice Id: 04546540435637
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