ATEC A.R.M.

Basic Information

• Brand Name: ATEC A.R.M.
• Primary DI: 00190376532400
• Version / Model: 102-100
• Company Name: ALPHATEC SPINE, INC.
• Labeler DUNS: 602465783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-14
• Public Version: 1
• Public Version Date: 2025-03-24
• Public Version Status: New
• Public Device Record Key: 6eef4091-b853-4e0c-be12-5acbdb4c248e

Device Description

MECH A-ARM

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: No
• 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
FQO	Table, operating-room, ac-powered	General, Plastic Surgery	878.4960	1
FWW	Table, operating-room, pneumatic	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67435	Operating table orthopaedic extension, electrically-powered	An electrically-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table to provide additional support to a patient's body during orthopaedic surgical procedures (e.g., lower-limb traction, spinal surgery). It typically consists of height, length and angle electrically-adjustable supports or telescopic bars/plates (e.g., leg spar). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190376532400	GS1

Customer Contacts

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