HiJAK™ Cervical

Basic Information

• Brand Name: HiJAK™ Cervical
• Primary DI: M68120190100070
• Version / Model: 2019-01-0007
• Catalog Number: 2019-01-0007
• Company Name: ATLAS SPINE, INC.
• Labeler DUNS: 140801007
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 2
• Public Version Date: 2020-09-07
• Public Version Status: Update
• Public Device Record Key: 51f58ec0-b128-4952-ab5b-2d0982fd3f9c

Device Description

Slap Hammer, HiJAK™ Cervical

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• 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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47814	Orthopaedic implantation hammering attachment	A surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68120190100070	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180675	000