Matrixx System
GUDID 00889929049280
Right Angled Monolythic Lateral Trial, 18Wx12H, 8°
NEXXT SPINE, LLC
General internal orthopaedic fixation system implantation kit| Primary Device ID | 00889929049280 |
| NIH Device Record Key | 2c4e5489-967a-4d60-8a99-e32559193363 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Matrixx System |
| Version Model Number | I62-ATR-18-12-8 |
| Company DUNS | 003489810 |
| Company Name | NEXXT SPINE, LLC |
| 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 | false |
| 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 | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929049280 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200969
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
[00889929049280]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-26 |
| Device Publish Date | 2022-07-18 |
On-Brand Devices [Matrixx System]
| 00889929032374 | TLIF Oblique 30D x 10W x 16H |
| 00889929032367 | TLIF Oblique 30D x 10W x 15H |
| 00889929032350 | TLIF Oblique 22D x 9W x 16H |
| 00889929032343 | TLIF Oblique 22D x 9W x 15H |
| 00889929032428 | Matrixx, Paddle Distractor, 17mm |
| 00889929032411 | Matrixx, Paddle Distractor, 16mm |
| 00889929032404 | Matrixx, Paddle Distractor, 15mm |
| 00889929032398 | Matrixx, Paddle Distractor, 14mm |
| 00889929032381 | Matrixx, Paddle Distractor, 6mm |
| 00889929032763 | TLIF Offset Inserter, Outer Shaft Assembly |
| 00889929032756 | TLIF Oblique Offset Inserter, Inner Shaft |
| 00889929032749 | TLIF Oblique Offset Inserter, Outer Shaft Assembly |
| 00889929032770 | Universal Remover |
| 00889929032732 | Lordotic TLIFO Solid, 30Dx10Wx8H, 6° |
| 00889929032725 | Lordotic TLIFO Solid, 26Dx9Wx8H, 6° |
| 00889929032718 | Lordotic TLIFO Solid, 22Dx9Wx8H, 6° |
| 00889929032701 | Lordotic TLIFO, 30Dx10Wx16H, 6° |
| 00889929032695 | Lordotic TLIFO, 30Dx10Wx15H, 6° |
| 00889929032688 | Lordotic TLIFO, 30Dx10Wx14H, 6° |
| 00889929032671 | Lordotic TLIFO, 30Dx10Wx13H, 6° |
| 00889929032664 | Lordotic TLIFO, 30Dx10Wx12H, 6° |
| 00889929032657 | Lordotic TLIFO, 30Dx10Wx11H, 6° |
| 00889929032640 | Lordotic TLIFO, 30Dx10Wx10H, 6° |
| 00889929032633 | Lordotic TLIFO, 30Dx10Wx9H, 6° |
| 00889929032626 | Lordotic TLIFO, 30Dx10Wx8H, 6° |
| 00889929032619 | Lordotic TLIFO, 26Dx9Wx16H, 6° |
| 00889929032602 | Lordotic TLIFO, 26Dx9Wx15H, 6° |
| 00889929032596 | Lordotic TLIFO, 26Dx9Wx14H, 6° |
| 00889929032589 | Lordotic TLIFO, 26Dx9Wx13H, 6° |
| 00889929032572 | Lordotic TLIFO, 26Dx9Wx12H, 6° |
| 00889929032565 | Lordotic TLIFO, 26Dx9Wx11H, 6° |
| 00889929032558 | Lordotic TLIFO, 26Dx9Wx10H, 6° |
| 00889929032541 | Lordotic TLIFO, 26Dx9Wx9H, 6° |
| 00889929032534 | Lordotic TLIFO, 26Dx9Wx8H, 6° |
| 00889929032527 | Lordotic TLIFO, 22Dx9Wx16H, 6° |
| 00889929032510 | Lordotic TLIFO, 22Dx9Wx15H, 6° |
| 00889929032503 | Lordotic TLIFO, 22Dx9Wx14H, 6° |
| 00889929032497 | Lordotic TLIFO, 22Dx9Wx13H, 6° |
| 00889929032480 | Lordotic TLIFO, 22Dx9Wx12H, 6° |
| 00889929032473 | Lordotic TLIFO, 22Dx9Wx11H, 6° |
| 00889929032466 | Lordotic TLIFO, 22Dx9Wx10H, 6° |
| 00889929032459 | Lordotic TLIFO, 22Dx9Wx9H, 6° |
| 00889929032442 | Lordotic TLIFO, 22Dx9Wx8H, 6° |
| 00889929032800 | TLIF Axial Inserter, Outer Shaft Assembly |
| 00889929032794 | TLIF Oblique Axial Inserter, Inner Shaft Assembly |
| 00889929032787 | TLIF Oblique Axial Inserter, Outer Shaft Assembly |
| 00889929033050 | Curve Implant Tamp |
| 00889929033043 | TLIF Oblique Lordotic Trial, 30x10x13mm |
| 00889929033036 | TLIF Oblique Lordotic Trial, 30x10x12mm |
| 00889929033029 | TLIF Oblique Lordotic Trial, 30x10x11mm |
Trademark Results [Matrixx System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRIXX SYSTEM 74561345 1986551 Dead/Cancelled |
REAL COLORS HOLDINGS, INC. 1994-08-15 |
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