Dymaxeon 46.4243

GUDID 00815500025404

Open Lateral Connector (60mm)

BACK 2 BASIC DIRECT, LLC

Bone-screw internal spinal fixation system, sterile
Primary Device ID00815500025404
NIH Device Record Keybeed11a3-304c-4c62-9548-07e587d9746b
Commercial Distribution Discontinuation2019-03-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDymaxeon
Version Model Number05.5
Catalog Number46.4243
Company DUNS043841348
Company NameBACK 2 BASIC DIRECT, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-447-5025
Emailinfo@back2basicsdirect.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815500025404 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-09
Device Publish Date2019-03-07

On-Brand Devices [Dymaxeon]

00815500024261DYMAXEON CURVED ROD SIZE Ø5.5 X 90mm (YELLOW)
00815500024254DYMAXEON CURVED ROD SIZE Ø5.5 X 80mm (YELLOW)
00815500024247DYMAXEON CURVED ROD SIZE Ø5.5 X 75mm (YELLOW)
00815500024230DYMAXEON CURVED ROD SIZE Ø5.5 X 70mm (YELLOW)
00815500024223DYMAXEON CURVED ROD SIZE Ø5.5 X 65mm (YELLOW)
00815500024216DYMAXEON CURVED ROD SIZE Ø5.5 X 60mm (YELLOW)
00815500024209DYMAXEON CURVED ROD SIZE Ø5.5 X 55mm (YELLOW)
00815500024193DYMAXEON CURVED ROD SIZE Ø5.5 X 50mm (YELLOW)
00815500024186DYMAXEON CURVED ROD SIZE Ø5.5 X 45mm (YELLOW)
00815500024179DYMAXEON CURVED ROD SIZE Ø5.5 X 40mm (YELLOW)
00815500024162DYMAXEON CURVED ROD SIZE Ø5.5 X 35mm (YELLOW)
00815500024155DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 400mm (GREEN)
00815500024148DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 350mm (BLUE)
00815500024131DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 300mm (BLUE)
00815500024124DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 250mm (YELLOW)
00815500024117DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 200mm (YELLOW)
00815500024100DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 150mm (VIOLET)
00815500024094DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 100mm (VIOLET)
00815500024087DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 70mm (GREEN)
00815500024070DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 50mm (GREEN)
00815500024063DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 45mm (GREEN)
00815500024056DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 40mm (GREEN)
00815500024049DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 50mm (BLUE)
00815500024032DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 45mm (BLUE)
00815500024025DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 40mm (BLUE)
00815500024018DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 90mm (YELLOW)
00815500024001DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 80mm (YELLOW)
00815500023998DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 70mm (YELLOW)
00815500023981DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 60mm (YELLOW)
00815500023974DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 55mm (YELLOW)
00815500023967DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 50mm (YELLOW)
00815500023950DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 45mm (YELLOW)
00815500023943DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 40mm (YELLOW)
00815500023936DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 90mm (VIOLET)
00815500023929DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 80mm (VIOLET)
00815500023912DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 70mm (VIOLET)
00815500023905DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 60mm (VIOLET)
00815500023899DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 55mm (VIOLET)
00815500023882DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 50mm (VIOLET)
00815500023875DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 45mm (VIOLET)
00815500023868DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 40mm (VIOLET)
00815500023851DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 35mm (VIOLET)
00815500023844DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 55mm (GREEN)
00815500023837DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 50mm (GREEN)
00815500023820Dymaxeon Pedicle Screw - Cap Include 6.5 x 45mm (Green)
00815500023813Dymaxeon Pedicle Screw - Cap Include 6.5 x 40mm (Green)
00815500023806DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 35mm (GREEN)
00815500023790DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 70mm (BLUE)
00815500023783DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 65mm (BLUE)
00815500023776DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 60mm (BLUE)

Trademark Results [Dymaxeon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DYMAXEON
DYMAXEON
86561740 4869761 Live/Registered
BACK 2 BASICS DIRECT, LLC
2015-03-12

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