Dark Star Deformity

Basic Information

• Brand Name: Dark Star Deformity
• Primary DI: B075101139105900
• Version / Model: 101139-10590
• Catalog Number: DSD3-10590
• Company Name: Republic Spine, LLC
• Labeler DUNS: 061891717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-21
• Public Version: 3
• Public Version Date: 2025-03-21
• Public Version Status: Update
• Public Device Record Key: 5369b6bb-1e16-44c3-8f2f-c8d98c88f74b

Device Description

Triple Lead Fine Pedicle Screw - Ø10.5mm x 90mm

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: Yes
• 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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B075101139105900	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223096	000

Device Sizes

Type	Value	Unit	Text
Length	90	Millimeter
Outer Diameter	10.5	Millimeter