Nex-D2 CBFBJ-70115
GUDID 00840314165879
HIGH-TOP POLYAXIAL SOLID SCREW, ST, Ø7.0mm x 115mm
NEXT ORTHOSURGICAL, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00840314165879 |
| NIH Device Record Key | 0825e075-ec1f-4eaa-9453-60d694b199e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nex-D2 |
| Version Model Number | CBFBJ-70115 |
| Catalog Number | CBFBJ-70115 |
| Company DUNS | 046767258 |
| Company Name | NEXT ORTHOSURGICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| 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 | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com | |
| Phone | 760-295-3600 |
| Info@nextorthosurgical.com |
Device Dimensions
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 115 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840314165879 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141291
FDA Product Code
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
[00840314165879]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-27 |
| Device Publish Date | 2024-09-19 |
On-Brand Devices [Nex-D2]
| 00840314116567 | SET SCREW, T-30 HEXALOBE |
| 00840314155467 | POLYAXIAL SCREW, LARGE OD, 8.0MM X 30MM |
| 00840314139115 | HIGH TOP UNIPLANAR SCREW, 4.0MM X 20MM |
| 00840314116574 | SET SCREW, CANNULATED, T-30 HEXALOBE |
| 00840314115560 | CANNULATED POLYAXIAL SCREW, 5.0MM X 20MM |
| 00840314114310 | FIXED SCREW, 4.0MM X 20MM |
| 00840314113085 | HIGH TOP POLYAXIAL SCREW, 4.0MM X 30MM |
| 00840314111814 | POLYAXIAL SCREW, 4.0MM X 40MM |
| 00840314107848 | UNIPLANAR SCREW, 4.0MM X 45MM |
| 00840314112866 | CBAAJ-78065 |
| 00840314112859 | CBAAJ-78060 |
| 00840314112842 | CBAAJ-78055 |
| 00840314112835 | CBAAJ-78050 |
| 00840314112828 | CBAAJ-78045 |
| 00840314112811 | CBAAJ-78040 |
| 00840314112804 | CBAAJ-78035 |
| 00840314112798 | CBAAJ-78030 |
| 00840314112781 | CBAAJ-78025 |
| 00840314112774 | CBAAJ-78020 |
| 00840314112767 | CBAAJ-70150 |
| 00840314112750 | CBAAJ-70140 |
| 00840314112743 | CBAAJ-70130 |
| 00840314112736 | CBAAJ-70125 |
| 00840314112729 | CBAAJ-70120 |
| 00840314112712 | CBAAJ-70115 |
| 00840314112705 | K141291 |
| 00840314112699 | CBAAJ-70105 |
| 00840314112682 | CBAAJ-70100 |
| 00840314112675 | CBAAJ-70095 |
| 00840314112668 | CBAAJ-70090 |
| 00840314112651 | CBAAJ-70085 |
| 00840314112644 | CBAAJ-70080 |
| 00840314112637 | CBAAJ-70075 |
| 00840314112620 | CBAAJ-70070 |
| 00840314112613 | CBAAJ-70065 |
| 00840314112606 | CBAAJ-70060 |
| 00840314112590 | CBAAJ-70055 |
| 00840314112583 | CBAAJ-70050 |
| 00840314112576 | CBAAJ-70045 |
| 00840314112569 | CBAAJ-70040 |
| 00840314112552 | CBAAJ-70035 |
| 00840314112545 | CBAAJ-70030 |
| 00840314112538 | CBAAJ-70025 |
| 00840314112521 | CBAAJ-70020 |
| 00840314112514 | CBAAJ-60150 |
| 00840314112507 | CBAAJ-60140 |
| 00840314112491 | CBAAJ-60130 |
| 00840314112484 | CBAAJ-60125 |
| 00840314112477 | CBAAJ-60120 |
| 00840314112460 | CBAAJ-60115 |
Trademark Results [Nex-D2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEX-D2 87177479 5342128 Live/Registered |
Next Orthosurgical, Inc. 2016-09-20 |
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