Dymaxeon®

Basic Information

• Brand Name: Dymaxeon®
• Primary DI: 00815500020867
• Version / Model: 06.0
• Catalog Number: 06.3340B
• Company Name: BACK 2 BASIC DIRECT, LLC
• Labeler DUNS: 043841348
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-01-15
• Public Version: 4
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 43a63b34-4fad-4bb3-b8cf-70cb869e921e
• Distribution End Date: 2019-02-14

Device Description

DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø8 x40mm (YELLOW)

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease	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
61324	Bone-screw internal spinal fixation system, sterile	An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815500020867	GS1
Unit of Use	10815500020864	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121786	000

Device Sizes

Type	Value	Unit	Text
Length	40	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: devices kept at room temperature or other standard conditions
• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit