DELTA 7MM BURR HOLE COVERPLATE, 0.5MM
DELTA - 70-92068
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 bioabsorbable materials (e.g., degradable polymer) 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 bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.
Environmental Conditions
No Data Available
Device Sizes
- Thickness: 0.5 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HRS
Device Name: Plate, Fixation, Bone
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: 888.3030
Third Party Flag: N
Medical Specialty: OR
Code: HBW
Device Name: Fastener, Plate, Cranioplasty
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
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: 882.5360
Third Party Flag: N
Medical Specialty: NE
Code: GXR
Device Name: Cover, Burr Hole
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
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: 882.5250
Third Party Flag: N
Medical Specialty: NE
Code: JEY
Device Name: Plate, Bone
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: 872.4760
Third Party Flag: N
Medical Specialty: DE
Device Identifiers
Device Id: 07613327400953
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