Dymaxeon

Basic Information

• Brand Name: Dymaxeon
• Primary DI: 00815500025282
• Version / Model: 06.0
• Catalog Number: 09.0725
• Company Name: BACK 2 BASIC DIRECT, LLC
• Labeler DUNS: 043841348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-22
• Public Version: 1
• Public Version Date: 2019-04-01
• Public Version Status: New
• Public Device Record Key: 04188aa1-6ed6-4f54-94ff-3595e2c33a03

Device Description

Rod pusher (angled)

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 Conditional
• 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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44804	Orthopaedic rod reducer	A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815500025282	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121786	000