Dark Star Deformity

Basic Information

• Brand Name: Dark Star Deformity
• Primary DI: B075100260020
• Version / Model: 100260-02
• Catalog Number: DS0001-L
• Company Name: Republic Spine, LLC
• Labeler DUNS: 061891717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-18
• Public Version: 1
• Public Version Date: 2025-11-26
• Public Version Status: New
• Public Device Record Key: ad572fb7-96e2-46b0-b6e5-40fe12fae8f7

Device Description

Polyaxial, Spring Loading Screwdriver - Long Configuration

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 Unsafe
• 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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32865	Orthopaedic implant driver	A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B075100260020	HIBCC

Customer Contacts

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