DELTA 2.2MM MESH 55X55X1.4MM

DELTA 2.2MM MESH 55X55X1.4MM
DELTA - 70-06350

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

Storage Environment Temperature - Degrees Celsius

49.00
N/A

Device Sizes

Thickness: 1.4 Millimeter

Width: 55.0 Millimeter

Length: 55.0 Millimeter

Thickness: 1.4 Millimeter
Width: 55.0 Millimeter
Length: 55.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: 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: 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

Code: MAI

Device Name: Fastener, Fixation, Biodegradable, Soft Tissue

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

Device Identifiers

Device Id: 04546540337337

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