HOLO

Basic Information

• Brand Name: HOLO
• Primary DI: 00850028694633
• Version / Model: 154000412
• Company Name: Surgalign Spine Technologies, Inc.
• Labeler DUNS: 014520584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-07
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 0bcda095-0832-4d57-9dd3-1077d281139b

Device Description

HOLO Patient Array

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62782	Optical surgical navigation device tracking system	A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850028694633	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211254	000