- Physicians Office Resource

LOCK 60110 INVISX SHELF PK 10 X 2 PK
INVISX™ - 60110

Device Description

A sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.

Environmental Conditions

No Data Available

Device Sizes

Width: 2.54 Millimeter

Width: 2.54 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GXN

Device Name: Plate, Cranioplasty, Preformed, Non-Alterable

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: 882.5330

Third Party Flag: N

Medical Specialty: NE

Device Identifiers

Device Id: 40643169496970

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00643169496972

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CT

Device Id: 00643169496972

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

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