Black Diamond Pedicle Screw System

Basic Information

• Brand Name: Black Diamond Pedicle Screw System
• Primary DI: B06210101028
• Version / Model: 1010-1028
• Catalog Number: 1010-1028
• Company Name: Osseus Fusion Systems, LLC
• Labeler DUNS: 933442068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-12
• Public Version: 3
• Public Version Date: 2024-08-27
• Public Version Status: Update
• Public Device Record Key: 7f5eff5d-57ec-4fb5-9952-2bfb64c3f609

Device Description

DILATOR #1 (HYBRID), BLK DIAMOND

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: 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
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B06210101028	HIBCC

Customer Contacts

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