DENALI® Spinal System

Basic Information

• Brand Name: DENALI® Spinal System
• Primary DI: 10888857008502
• Version / Model: 101-85500D-SG
• Catalog Number: 101-85500D-SG
• Company Name: VB Spine LLC
• Labeler DUNS: 119508156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-13
• Public Version: 2
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: e61c5bea-b331-429e-8368-18592e01648c

Device Description

Buttress Ring Size Ø5.5 mm

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNI	Orthosis, spinal pedicle fixation	Orthopedic	888.3070	2
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2
MNH	Orthosis, spondylolisthesis spinal fixation	Orthopedic	888.3070	2
KWQ	Appliance, fixation, spinal intervertebral body	Orthopedic	888.3060	2
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis	Orthopedic	888.3070	2
NKB	Thoracolumbosacral pedicle screw system	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888857008502	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.5	Millimeter