Dymaxeon 06.6341B

GUDID 00815500023684

DYMAXEON 6.0 POLYAXIAL PEDICLE SCREW Ø4.5 x 30mm (VIOLET)

BACK 2 BASIC DIRECT, LLC

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00815500023684
• NIH Device Record Key: 1506b628-1d51-49f3-835e-66592b3fb89f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dymaxeon
• Version Model Number: 6.0
• Catalog Number: 06.6341B
• Company DUNS: 043841348
• Company Name: BACK 2 BASIC DIRECT, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2164475025
• Email: info@back2basicsdirect.com
• Phone: 2164475025
• Email: info@back2basicsdirect.com
• Phone: 2164475025
• Email: info@back2basicsdirect.com

Device Dimensions

• Length: 30 Millimeter
• Length: 30 Millimeter
• Length: 30 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815500023684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121786

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-08

On-Brand Devices [Dymaxeon]

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