FDA UDI
In Commercial Distribution
🇺🇸 United States
NEXXT MATRIXX® SI System
DI: 00889929054291
·
Model: I64-05-13
·
NEXXT SPINE, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NEXXT MATRIXX® SI System
- Primary DI
- 00889929054291
- Version / Model
- I64-05-13
- Company Name
- NEXXT SPINE, LLC
- Labeler DUNS
- 003489810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-24
- Public Version
- 1
- Public Version Date
- 2025-05-02
- Public Version Status
- New
- Public Device Record Key
- 7299bcd9-6311-43ae-9262-88d27cb7739d
Device Description
Large Working Portal
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 888.3040 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58849 | Sacroiliac joint transarticular fixation/arthrodesis implantation kit | A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889929054291 | GS1 |
Customer Contacts
- Phone
- 317-436-7801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243838 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 20.4 | Millimeter | |
| Length | 130 | Millimeter |