INTEGRATE-C

Basic Information

• Brand Name: INTEGRATE-C
• Primary DI: G2308H1FT12L100
• Version / Model: Trial-Large 20x15x12mm 10deg
• Catalog Number: T12L10
• Company Name: Happe Spine, LLC
• Labeler DUNS: 118446952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-19
• Public Version: 1
• Public Version Date: 2024-02-27
• Public Version Status: New
• Public Device Record Key: 016f0568-66f9-4574-9545-f6c0c74262e5

Device Description

Single End Trial - Large 20x15x12mm 10deg

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G2308H1FT12L100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]