Dymaxeon® 06.3402B
GUDID 00815500020805
DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø7.5 x50mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00815500020805 |
| NIH Device Record Key | c7fb34ff-42f2-46ec-99b3-b2c32f3ca228 |
| Commercial Distribution Discontinuation | 2019-02-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dymaxeon® |
| Version Model Number | 06.0 |
| Catalog Number | 06.3402B |
| Company DUNS | 043841348 |
| Company Name | BACK 2 BASIC DIRECT, LLC |
| Device Count | 2 |
| 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 | true |
| 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 | +1(216)447-5025 |
| info@back2basicsdirect.com | |
| Phone | +1(216)447-5025 |
| info@back2basicsdirect.com | |
| Phone | +1(216)447-5025 |
| info@back2basicsdirect.com |
Device Dimensions
| Length | 50 Millimeter |
| Length | 50 Millimeter |
| Length | 50 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815500020805 [Primary] |
| GS1 | 10815500020802 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121786
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE 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 | 4 |
| Public Version Date | 2019-02-15 |
| Device Publish Date | 2016-01-15 |
On-Brand Devices [Dymaxeon®]
| 00815500023660 | DYMAXEON OPEN POLYAXIAL PEDICLE SCREW Ø5.5 x30mm (BLUE) |
| 00815500023653 | DYMAXEON OPEN POLYAXIAL PEDICLE SCREW Ø5.5 x25mm (BLUE) |
| 00815500023288 | DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø7.5 x45mm (VIOLET) |
| 00815500023271 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X80mm (GREEN) |
| 00815500023264 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X70mm (GREEN) |
| 00815500023257 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X60mm (GREEN) |
| 00815500023240 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X55mm (GREEN) |
| 00815500023233 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X50mm (GREEN) |
| 00815500023226 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X45mm (GREEN) |
| 00815500023219 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X40mm (GREEN) |
| 00815500023202 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X60mm (GREEN) |
| 00815500023196 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X55mm (GREEN) |
| 00815500023189 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X50mm (BLUE) |
| 00815500023172 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X45mm (BLUE) |
| 00815500023165 | DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X40mm (BLUE) |
| 00815500023158 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x90mm (YELLOW) |
| 00815500023141 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x80mm (YELLOW) |
| 00815500023134 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x70mm (YELLOW) |
| 00815500023127 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x60mm (YELLOW) |
| 00815500023110 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x55mm (YELLOW) |
| 00815500023103 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x50mm (YELLOW) |
| 00815500023097 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x45mm (YELLOW) |
| 00815500023080 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø8 x40mm (YELLOW) |
| 00815500023073 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x90mm (VIOLET) |
| 00815500023066 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x80mm (VIOLET) |
| 00815500023059 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x70mm (VIOLET) |
| 00815500023042 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x60mm (VIOLET) |
| 00815500023035 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x55mm (VIOLET) |
| 00815500023028 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x50mm (VIOLET) |
| 00815500023011 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x45mm (VIOLET) |
| 00815500023004 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x40mm (VIOLET) |
| 00815500022991 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x35mm (VIOLET) |
| 00815500022984 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x90mm (BLUE) |
| 00815500022977 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x80mm (BLUE) |
| 00815500022960 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x70mm (BLUE) |
| 00815500022953 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x60mm (BLUE) |
| 00815500022946 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x55mm (BLUE) |
| 00815500022939 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x50mm (BLUE) |
| 00815500022922 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x45mm (BLUE) |
| 00815500022915 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7 x40mm (BLUE) |
| 00815500022908 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x90mm (VIOLET) |
| 00815500022892 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x80mm (VIOLET) |
| 00815500022885 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x70mm (VIOLET) |
| 00815500022878 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x60mm (VIOLET) |
| 00815500022861 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x55mm (VIOLET) |
| 00815500022854 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x50mm (VIOLET) |
| 00815500022847 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x45mm (VIOLET) |
| 00815500022830 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x40mm (VIOLET) |
| 00815500022823 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6.5 x35mm (VIOLET) |
| 00815500022816 | DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø6 x70mm (GREEN) |
Trademark Results [Dymaxeon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYMAXEON 86561740 4869761 Live/Registered |
BACK 2 BASICS DIRECT, LLC 2015-03-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.